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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
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 12, 2018 Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic d... A size 22mm threaded peg was found in the package of a 10mm unit. Class II Zimmer Biomet, Inc.
Jun 22, 2018 Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-00... The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was u... Class II Zimmer Biomet, Inc.
Jun 18, 2018 Connecting Bolt, Model 14-442093 Product was manufactured from the incorrect material, which shows a potential decrease in the fat... Class II Zimmer Biomet, Inc.
Jun 8, 2018 ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item... Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingl... Class II Zimmer Biomet, Inc.
Jun 8, 2018 ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip pros... Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingl... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-77... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 24, 2018 Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers E... Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is... Class II Zimmer Biomet, Inc.
May 18, 2018 Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (s... One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may le... Class II Zimmer Biomet, Inc.
May 16, 2018 G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 11, 2018 Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for u... The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 si... Class II Zimmer Biomet, Inc.
Apr 5, 2018 Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Crani... The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on ... Class II Zimmer Biomet, Inc.
Apr 3, 2018 Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, ... There is a potential dry blast irregularity on the locking collar screws packaged with the lockin... Class II Zimmer Biomet, Inc.
Apr 2, 2018 Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, met... Two lots of different sized modular heads potentially commingled. Risks include delay in surgery ... Class II Zimmer Biomet, Inc.
Apr 2, 2018 Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/... Two lots of different sized modular heads potentially commingled. Risks include delay in surgery ... Class II Zimmer Biomet, Inc.
Mar 29, 2018 Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number ... There is a potential for debris in the hole on the superior lateral aspect of the device as a res... Class II Zimmer Biomet, Inc.
Mar 28, 2018 Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattac... Specific lots of the device were overexposed during EtO sterilization. This may lead to revision ... Class II Zimmer Biomet, Inc.
Mar 28, 2018 Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattac... Specific lots of the device were overexposed during EtO sterilization. This may lead to revision ... Class II Zimmer Biomet, Inc.
Mar 28, 2018 Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattac... Specific lots of the device were overexposed during EtO sterilization. This may lead to revision ... Class II Zimmer Biomet, Inc.
Mar 28, 2018 Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattac... Specific lots of the device were overexposed during EtO sterilization. This may lead to revision ... Class II Zimmer Biomet, Inc.
Mar 28, 2018 Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattac... Specific lots of the device were overexposed during EtO sterilization. This may lead to revision ... Class II Zimmer Biomet, Inc.
Mar 28, 2018 Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattac... Specific lots of the device were overexposed during EtO sterilization. This may lead to revision ... Class II Zimmer Biomet, Inc.
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm lengt... Potential failure of sterile packaging seal. 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.