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FDA (Device enforcement)Recalled 2023-07-26class ii

Zimmer, Inc.: M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)

Hazard

The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

Details from the source

Reason for recall: The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands. Quantity: 24 units Lot/code info: Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215

UPC codes

00771100640, 00889024131699, 00771100440, 00889024131613

Source

Official record: FDA (Device enforcement)

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

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