Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 340 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 380 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 420 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 440 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 460 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail 130¿ 13 mm x 180 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 260 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 280 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 300 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 340 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 380 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 420 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 440 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 320 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 440 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 260 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 280 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 320 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 360 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 400 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 420 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 460 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 260 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 280 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 320 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 340 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 380 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 420 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 460 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 260 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 360 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 380 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 440 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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