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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Mar 8, 2023 MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device There is a potential for breakage of the small screw used to affix the anti-backout plate. Class II Medacta Usa Inc
Mar 8, 2023 MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device There is a potential for breakage of the small screw used to affix the anti-backout plate. Class II Medacta Usa Inc
Mar 8, 2023 MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device There is a potential for breakage of the small screw used to affix the anti-backout plate. Class II Medacta Usa Inc
Mar 8, 2023 MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion de... There is a potential for breakage of the small screw used to affix the anti-backout plate. Class II Medacta Usa Inc
Mar 8, 2023 MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device There is a potential for breakage of the small screw used to affix the anti-backout plate. Class II Medacta Usa Inc
Mar 8, 2023 MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device There is a potential for breakage of the small screw used to affix the anti-backout plate. Class II Medacta Usa Inc
Oct 27, 2022 NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based co... A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of ... Class II Medacta Usa Inc
Apr 13, 2022 GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 A Size 2 trial baseplate was assembled with Size 1 instrument sets. Class II Medacta Usa Inc
Nov 4, 2019 Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through... Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional co... Class II Medacta Usa Inc
Nov 15, 2017 Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementle... Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem. Class II Medacta Usa Inc
Oct 24, 2017 The GMK knee system: designed for cemented use in total knee arthroplasty. S... Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of appro... Class II Medacta Usa Inc
May 19, 2017 Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H... One lot of product does not include a screw for attachment to the tibial base plate. Class II Medacta Usa Inc
Dec 7, 2016 Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480... Damaged packaging, lack of sterility assurance Class II Medacta Usa Inc
Apr 17, 2015 GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthope... Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws inst... Class II Medacta Usa
Oct 21, 2014 The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert th... The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and co... Class II Medacta Usa
Sep 22, 2014 GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignm... Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension R... Class II Medacta Usa
Dec 17, 2012 Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Meda... The tip of the Quadra Trial Broach size 0, broke during a surgery. Class II Medacta Usa Inc
Jan 15, 2010 Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.01... Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit proper... Class II Medacta Usa Inc
Oct 13, 2008 Quadra S Offset Broach Handle The offset broach handle is intended to atta... Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potent... Class II Medacta Usa 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.