Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall OSTEOVATION 3CC IMPACTFORMULA Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OSTEOVATION 5CC IMPACTFORMULA Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OSTEOVATION RMX Injectable BVF 5CC Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OSTEOVATION 10 CC IMPACT FORMULA Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OSTEOVATION RMX 10 CC Injectable Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Power supply provided with Afinion 2 The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedJun 10, 2020ClassClass IIStatusOngoingWhereNew Jersey
- Medical device recall Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment… Potential disconnection of tubing set. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single… Potential disconnection of tubing set. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended… Potential disconnection of tubing set. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is… Potential disconnection of tubing set. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OLYMPUS ShockPulse-SE Lithotripsy System A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Michigan, North Carolina, Nebraska, New Mexico, Ohio, Oklahoma, Pennsylvania and Texas named
- Medical device recall FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple… Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 10, 2020ClassClass IIStatusOngoingWhereNationwide, and Illinois and New York named
- Medical device recall Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The… In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 10, 2020ClassClass IIStatusOngoingWhereNationwide, and Illinois and New York named
- Medical device recall Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems… In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 10, 2020ClassClass IIStatusOngoingWhereNationwide, and Illinois and New York named
- Medical device recall TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative… One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR… Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Ohio, South Carolina, Virginia and Wisconsin named
- Medical device recall Pressure Monitoring Set, C-PMS, G02838 The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report48 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Pressure Monitoring Tray, C-PMSY, G02854 The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report48 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall AC Powered hospital adjustable bed. Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Georgia, Mississippi, New York, Pennsylvania and Utah
- Medical device recall Medtronic Implantable Insulin Pump System Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NobelActive Internal NP 3.5x15mm Endosseus dental implant The top label for dental implant may incorrectly indicate the implant length. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report28 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, Nevada, New York, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Washington and Wisconsin
- Medical device recall EQUISTREAM¿ XK Long-Term Hemodialysis Catheter Incorrect Peel-Apart Introducer Sheath in Kit. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report24 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Montana, North Carolina, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall EQUISTREAM¿ XK Long-Term Hemodialysis Catheter Incorrect Peel-Apart Introducer Sheath in Kit. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report24 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Montana, North Carolina, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM There are reports of inadequate locking of the extended tab screws. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
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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