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FDA (Device enforcement)Recalled 2018-03-01closedclass ii

Zimmer Biomet, Inc.: 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-

Is my product affected?

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: 00-7711-007-40

  • UPC 00889024131736

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

What happened

Zimmer Biomet, Inc. recalled 12 packages of Zimmer M/L Taper Hip Prosthesis femoral stems 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 have Lot Number 63716611 and were distributed across twelve U.S. states (Arizona, California, Connecticut, Indiana, Maryland, Michigan, Minnesota, New Jersey, New York, Oregon, and Washington), as well as Puerto Rico, China, and India.

The recall notice does not specify a remedy or corrective action 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: 12 Lot/code info: Lot Number: 63716611; UDI: (01)00889024131736(17)270731(10)63716611

Source

Official record: FDA (Device enforcement) ↗

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

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