Zimmer Biomet, Inc.: Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10

Is my product affected?

Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10

• UPC 00889024131606

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet, Inc. recalled 24 hip implant packages that were mislabeled. The packages were labeled as size 7.5 Extended Offset Reduced Neck length hip implants but actually contained Size 4 Standard Reduced Neck length taper hip implants instead. The affected implants were distributed across multiple U.S. states (Arizona, California, Connecticut, Indiana, Maryland, Michigan, Minnesota, New Jersey, New York, Oregon, and Washington), Puerto Rico, China, and India. The recalled products correspond to two lot numbers: 63716613 and 63716614, with their associated Universal Device Identifiers (UDIs).

The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.

Details from the source

Reason for recall: Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. Distribution: Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India. Quantity: 24 Lot/code info: Lot Number: 63716613, UDI: (01)00889024131606(17)270731(10)63716613; Lot Number: 63716614, UDI: (01)00889024131606(17)279731(10)63716614

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-402018-03-01
• Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction2018-02-28
• Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading car2018-03-02
• Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfect2018-03-02
• PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.2018-02-28

All FDA (Device enforcement) recalls