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Browse Device Recalls

437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 437 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 437 FDA device recalls.

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DateProductReasonClassFirm
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indica... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Jul 26, 2023 M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item N... The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, a... Class II Zimmer, Inc.
Jun 27, 2023 Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 hole... Thread form issue of the locking holes in that the locking screws would not properly mate with th... Class II Zimmer, Inc.
May 19, 2023 NexGen Precoat Stemmed Tibial Plate Size 5 Device outer packaging was incorrectly labeled. Class II Zimmer, Inc.
Feb 27, 2023 CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular he... Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Fem... Class II Zimmer, Inc.
Dec 7, 2022 Identity Shoulder System Resection Planer 35mm Resection Planer Two planers were found to be unusable during sawbones shoulder training. Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Aug 25, 2022 G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 ... The outer sterile package cavity has a corner wall thickness that is below the specification. The... Class II Zimmer, Inc.
Nov 24, 2015 Persona EM Proximal Tube, orthopedic manual surgical instrument for use with ... Complaints that the ratchet teeth of the tube are not latching onto the rod. Class II Zimmer, Inc.
Nov 24, 2015 Persona EM Distal Rod, orthopedic manual surgical instrument for use with Per... Complaints that the ratchet teeth of the tube are not latching onto the rod. Class II Zimmer, Inc.
Nov 10, 2015 Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trig... The firm identified a malfunction which made it possible for a handpiece to start by itself when ... Class II Zimmer, Inc.
Nov 10, 2015 Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trig... The firm identified a malfunction which made it possible for a handpiece to start by itself when ... Class II Zimmer, Inc.
Aug 27, 2015 Zimmer Guide Wires for orthopedic procedures. Product labeling of these sterile guide wires (external carton label and patient record label) st... Class II Zimmer, Inc.
Aug 11, 2015 Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrume... It was found through review of open Complaints and stock investigations that a single lot of Zimm... Class II Zimmer, Inc.
Jun 17, 2015 ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device. A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fat... Class II Zimmer, Inc.
May 18, 2015 M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (meta... Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinecti... Class I Zimmer, Inc.
Apr 30, 2015 PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual ... Potential for uncured adhesive between the metal threaded insert and the impactor block to leak o... Class II Zimmer, Inc.
Apr 29, 2015 Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail... The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compat... Class II Zimmer, Inc.
Apr 2, 2015 NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Int... The affected lot is being recalled because it was packaged without the locking screw. The lockin... Class II Zimmer, Inc.
Mar 10, 2015 Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Person... Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking ... Class II Zimmer, Inc.
Feb 5, 2015 Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem ... PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. Class II Zimmer, Inc.
Jan 28, 2015 Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Pa... An increase in complaints of loosening and radiolucent lines. Class II Zimmer, Inc.
Dec 11, 2014 Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots ... Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of s... Class II Zimmer, Inc.
Dec 8, 2014 Osteobond Bone Cement Bone cement monomer is kitted with bone cement powde... Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between ... Class II Zimmer, Inc.
Dec 4, 2014 Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Ti... The affected lot was supplied by contract manufacturer and are potentially subject to disassociat... Class II Zimmer, Inc.
Nov 25, 2014 Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Ma... Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x ... Class II Zimmer, Inc.
Oct 14, 2014 Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads ... To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal T... Class II Zimmer, Inc.
Oct 14, 2014 Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibi... To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal T... Class II Zimmer, Inc.
Oct 9, 2014 Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is i... Cleaning process validation failure. Class II Zimmer, Inc.
Oct 7, 2014 The Persona Tibial Articular Surface Inserter is a sterilizable instrument in... Affected product did not undergo heat treatment hardening step leading to the potential for defor... Class II Zimmer, Inc.
Oct 2, 2014 Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in ... Failed to meet established requirements for sterile barrier integrity due to a breach of the inne... Class II Zimmer, Inc.
Oct 1, 2014 Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 6... The affected products are missing polar boss threads. Class II Zimmer, Inc.
Sep 9, 2014 Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile... The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cort... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System Tibial Articular Surface Provisional Lef... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System Constrained Tibial Articular Surface Pro... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Jul 30, 2014 Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical... Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position. Class II Zimmer, Inc.
Jul 30, 2014 Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Tro... Internal review found that five (5) PFJ implant forgings were identified as have forged laps duri... Class II Zimmer, Inc.
Jul 23, 2014 VER2 D8L OFFSET RASP HANDLE, RT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left) The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 VER2 HANDLE, PIN REWORK, LT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, 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.