FDA-Device2023-12-27Class II
Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
Biomet, Inc.
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.
Sold states
US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.
Affected count
10 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0570-2024Don't want to check this manually?
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