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Zimmer Biomet Recalls

875 recalls on record · January 20, 2016 to December 30, 2020 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number 810M6550 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number 810M5540 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
June 10, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cerv
Hazard: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
March 4, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105
Hazard: Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
February 12, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)0088902427400
Hazard: The lot contained two outer pins instead of one outer and one inner pin.
February 12, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
Hazard: Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label
February 5, 2020Medical DevicesFDA
Zimmer Biomet, Inc. recalls ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general
Hazard: Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach
December 11, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 4756
Hazard: Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
December 11, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
Hazard: Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to faci
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery system
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-11464
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Comprehensive RS Cleat CAP, Item No. 110300
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
December 4, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202
Hazard: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.