Z-0570-2024 Class II Ongoing

Recalled by Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
December 27, 2023
Initiation Date
November 2, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 units

Product Description

Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02

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 Pattern

US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.

Code Information

UDI-DI: 00889024430563; Lot Number: 3145300