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Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 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 1,125 FDA device recalls.

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DateProductReasonClassFirm
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.
Jan 11, 2016 NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotib... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous unce... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads N... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 7.5 INCH BEADED FC 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 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 NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous ... 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 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, pate... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous unce... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Dec 9, 2015 Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight ... The product on the package label did not match what was inside the package. The label was for par... Class II Zimmer Biomet, Inc.
Dec 9, 2015 Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; ... Product on the package label did not match what was inside the package. The label was for part... Class II Zimmer Biomet, Inc.
Dec 2, 2015 Green Mamba Suture Passer There may be a separation and an insufficient weld between the spring and washer. The weld betwe... Class II Biomet, Inc.
Dec 2, 2015 Black Mamba Suture Passer There may be a separation and an insufficient weld between the spring and washer. The weld betwe... Class II Biomet, Inc.
Nov 20, 2015 A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization ... These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in th... Class II Biomet, Inc.
Nov 17, 2015 Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a post... Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through prod... Class II Zimmer Biomet, Inc.
Nov 17, 2015 Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), ... PMMA is listed as a material on the label but the product does not contain PMMA. Class II Biomet, Inc.
Oct 29, 2015 Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device Th... A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolv... Class II Zimmer Biomet, Inc.
Jul 28, 2015 Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. The device was assembled without screw hole plugs. Class II Biomet, Inc.
Jun 17, 2015 A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument. Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surg... Class II Biomet, Inc.
Jun 4, 2015 A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection. Class II Biomet, Inc.
Jun 4, 2015 A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedi... The thread location on one of the thread holes is offset from the axis of the predrill hole. The ... Class II Biomet, Inc.
Jun 3, 2015 Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill gui... Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an i... Class II Biomet, Inc.
Jun 3, 2015 Gentle Threads Interference Screw 10x25mm Round Head. An interference fixa... Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed wit... Class II Biomet, Inc.
Jun 3, 2015 Gentle Threads Interference Screw 9x35mm Full Thread. An interference fix... Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed wit... Class II Biomet, Inc.
May 1, 2015 Unilateral external fixation ankle clamp Product Usage: Unilateral extern... Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. Thi... Class II Biomet, Inc.
Apr 22, 2015 Vanguard M Unicondylar Tibial Trial For use during knee joint replacement. The Left and Right orientation of the trial was incorrectly etched on one side. When the instrum... Class II Biomet, Inc.
Apr 16, 2015 MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 16, 2015 Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; T... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 16, 2015 Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM M... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 16, 2015 Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Mar 18, 2015 LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Pro... A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number... Class II Biomet, Inc.
Feb 26, 2015 ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligame... The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were n... Class II Biomet, Inc.
Feb 26, 2015 Ziploop Button Product Usage: The Ziploop Button is a non-resorbable syst... The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were n... Class II Biomet, Inc.
Jan 9, 2015 Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... Class II Biomet, Inc.
Jan 9, 2015 Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis co... Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... Class II Biomet, Inc.
Jan 7, 2015 Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Ada... The taper adaptor is missing from the packaging, which may result in a delay in surgery greater t... Class II Biomet, Inc.
Dec 2, 2014 Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identi... After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... Class II Biomet, Inc.
Dec 2, 2014 Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Nam... After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... Class II Biomet, Inc.
Nov 6, 2014 ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to gu... Potential failure of a force feedback sensor that may result in continued movement of an operatin... 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.