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Browse Device Recalls

875 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 875 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 875 FDA device recalls.

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DateProductReasonClassFirm
Feb 28, 2017 Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and acc... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/po... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and acc... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 17x200mm, Sterile, Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 27, 2017 MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning an... Unapproved change made by the supplier. Class II Zimmer Biomet, Inc.
Feb 27, 2017 MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning ... Unapproved change made by the supplier. Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Custom parts Product Usage: Custom Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Extremities, Shoulders and Elbows BioModular... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Hips Active Articulation ArComXL Bearings A... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants BIO PLUG 10MM Product Usage: Non-weig... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Knees Revision Tibial Tray Systems Oxford P... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Sports Med Repicci II Tibial Components P... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 14, 2017 Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates... Digital templates were created with the incorrect files. Class II Zimmer Biomet, Inc.
Jan 10, 2017 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, B... The identification of the devices was non-conforming with off-centered slots and the no-go gage s... Class II Zimmer Biomet, Inc.
Jan 4, 2017 Vanguard Total Knee System Vanguard Open Box Femoral Components Item Numb... packaging of some femoral components was incorrectly labeled as either smaller or larger and/or a... Class II Zimmer Biomet, Inc.
Dec 20, 2016 Comprehensive Reverse Shoulder System Humeral Tray Model 115340 Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fractu... Class I Zimmer Biomet, Inc.
Dec 19, 2016 Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComX... Product complaints indicated that the part and lot numbers on the packaging differed from the phy... Class II Zimmer Biomet, Inc.
Dec 19, 2016 RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3m... Product complaints indicated that the part and lot numbers on the packaging differed from the phy... Class II Zimmer Biomet, Inc.
Dec 16, 2016 Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrai... labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the ... Class II Zimmer Biomet, Inc.
Dec 15, 2016 Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM I... Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to p... Class II Zimmer Biomet, Inc.
Dec 6, 2016 Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Ste... Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mis... Class II Zimmer Biomet, Inc.
Oct 11, 2016 ROSA Brain, 3.0.0 The device is intended for the spatial positioning and ori... Complaint of the head holder connector locking up mechanically when tightened. Class II Zimmer Biomet, Inc.
Sep 28, 2016 Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece Complaints have been reported that the handpiece is inoperable. The investigation found that the ... Class II Zimmer Biomet, Inc.
Aug 16, 2016 Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This pro... Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Mor... Class II Zimmer Biomet, Inc.
Aug 9, 2016 Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve ... Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interch... Class II Zimmer Biomet, Inc.
Aug 9, 2016 Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and O... Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interch... Class II Zimmer Biomet, Inc.
Aug 9, 2016 Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and... Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal F... Class II Zimmer Biomet, Inc.
Aug 8, 2016 Vanguard 360 Revision Knee System Knee prostheses The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolt... Class II Zimmer Biomet, Inc.
Aug 2, 2016 Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smoot... The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and o... Class II Zimmer Biomet, Inc.
Jul 29, 2016 ROSA BRAIN 3.0.0 Non-conforming product label. Class II Zimmer Biomet, Inc.
Jul 20, 2016 ROSA Brain 3.0.0 Usage: The device is intended for the spatial positionin... Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller. Class II Zimmer Biomet, Inc.
May 27, 2016 ROSA Brain 3.0 Intended for the spatial positioning and orientation of instr... Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device. Class II Zimmer Biomet, Inc.
May 11, 2016 Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Inst... Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instrument... Class II Zimmer Biomet, Inc.
Apr 8, 2016 ROSA Surgical Device 2.5.8 Potential for software to change the final tool orientation for the command position without comm... Class II Zimmer Biomet, Inc.
Feb 11, 2016 M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prost... Class II Zimmer Biomet, Inc.
Jan 20, 2016 Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotac... Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-const... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constr... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, c... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femo... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained,... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, ceme... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.