FDA Device recall Z-0569-2024
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 by Biomet, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0569-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-02 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomet |
| Distribution | AL, CA, MD, MI, NC, OH, OK, TN, TX |
Product
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Reason
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.
Identifiers
| code_info | UDI-DI: 00889024430556; Lot Number: 3145299 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0569-2024%22
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