FDA recall Z-0570-2024

Biomet, Inc. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2023-11-02
Report date
2023-12-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0570-2024