Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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 5, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Arrow(R) VPS(R) Access Kit for use with 4 Fr There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Massachusetts, Missouri, North Carolina, New York, Oregon and South Dakota named
- Medical device recall ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term… There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Massachusetts, Missouri, North Carolina, New York, Oregon and South Dakota named
- Medical device recall ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term… There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Massachusetts, Missouri, North Carolina, New York, Oregon and South Dakota named
- Medical device recall ArrowADVANTAGE5” Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable… There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Massachusetts, Missouri, North Carolina, New York, Oregon and South Dakota named
- Medical device recall BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G Product mislabel. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Illinois, Louisiana, Maine, Michigan, North Carolina, North Dakota, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina and Virginia named
- Medical device recall ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Georgia, Michigan, Ohio and Texas named
- Medical device recall ImplantDirect Legacy(TM) 3 Implant, 13MM L One reported complaint and discovered that the outer vial was out of round and undersized. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in… Stent length on the label may not match the length of the stent itself. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, Iowa, Illinois, Kentucky, Massachusetts, North Carolina, Nebraska, South Carolina, Tennessee and Virginia named
- Medical device recall Volcano Imaging System s5i On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect… Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Delaware, Illinois, Indiana, Massachusetts and Pennsylvania named
- Medical device recall SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens… Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when… Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L:… Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when… Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Monarch Airway Clearance System Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other… Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Arkon Anesthesia Delivery System Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 29, 2017ClassClass IStatusTerminatedWhereNationwide, and Alabama, Colorado, Connecticut, Florida, Maine, Mississippi, North Carolina, New Mexico and Wyoming named
- Medical device recall ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to… Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportDistrict of Columbiathe one state its words name PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereDistrict of Columbia
- Medical device recall SURPLUG MICRO CONNECTOR ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T,… Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T,… Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T) Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961,… Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr Products labeled as sterile were distributed prior to sterilization Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereFlorida, Georgia, Indiana, Maryland, New Jersey, Tennessee and Utah
- Medical device recall MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in Products labeled as sterile were distributed prior to sterilization Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereFlorida, Georgia, Indiana, Maryland, New Jersey, Tennessee and Utah
- Medical device recall 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Illinois, Michigan, Minnesota and Missouri
- Medical device recall ROSA Surgical Device 2.5.8 Potential for software to change the final tool orientation for the command position without command. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report16 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Michigan, Missouri, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall ROSA BRAIN 3.0.0 Non-conforming product label. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits… Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits… Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case. Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits… Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits… Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case. Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits… Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case. Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel… Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
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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