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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
May 5, 2020 Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Num... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
Jan 7, 2020 THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 ... Potential increase in fracture rate was detected during internal testing, in addition to potentia... Class II Zimmer Biomet, Inc.
Dec 23, 2019 Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00 Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed ... Class II Zimmer Biomet, Inc.
Dec 19, 2019 ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332... Potential issue associated with the instrument -end of the shaft could fail to effectively mate w... Class II Zimmer Biomet, Inc.
Dec 12, 2019 Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Mode... The lot contained two outer pins instead of one outer and one inner pin. Class II Zimmer Biomet, Inc.
Oct 25, 2019 Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic ma... Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo... Class II Zimmer Biomet, Inc.
Oct 25, 2019 Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manua... Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo... Class II Zimmer Biomet, Inc.
Oct 10, 2019 SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 472358... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item N... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 3285... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 3... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 010055... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 002348... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 0057... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticular locking plate elbow-sterile, Item Nos. 47235800503 4723580050... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 002232... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 010029605... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 472... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 0058500... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 4724931801... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 4723571... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107 Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 0023470030... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 LPS-MOB ART SURF IMPL D 9MM Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various fixation systems and accessories, Item Nos. 00224000916 00224000918 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various fixation systems and accessories, Item Nos. 00118100522 00118100527 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 008... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various temporary devices used during the implantation of the device system: ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 008... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 328554... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Connection Screw for NCB Plate, Item No. 0202266002 Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 004300007... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). 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.