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FDA (Device enforcement)Recalled 2023-11-02class ii

Biomet, Inc.: Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01

Hazard

One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.

Details from the source

Reason for recall: One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device. Distribution: US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands. Quantity: 10 units Lot/code info: UDI-DI: 00889024430556; Lot Number: 3145299

UPC codes

00889024430556

Source

Official record: FDA (Device enforcement)

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

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