Biolox Ceramic Option Head Zimmer 12/14 40mm +0 — Class II medical device recall Z-0570-2024
Ongoing recall by Biomet, Inc., reported 2023-12-27, distributed in AL, CA, MD, MI, NC, OH, OK, TN…. One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter
| Recall number | Z-0570-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2023-11-02 |
| Classified | 2023-12-18 |
| Reported by FDA | 2023-12-27 |
| Distributed | AL, CA, MD, MI, NC, OH, OK, TN, TX |
| Countries outside the US | NL |
| Quantity | 10 units |
| UPC / GTIN / UDI-DI | 00889024430563 |
| Lot numbers | 3145300 |
| Model numbers | 00-8777-040-02 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0570-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.