Zimmer Biomet Ceramic Head — Class II medical device recall Z-1649-2025
Ongoing recall by Zimmer, Inc., reported 2025-04-30, distributed nationwide. The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm D
| Recall number | Z-1649-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2025-03-24 |
| Classified | 2025-04-21 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, HK, PA |
| Quantity | 160 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00887868376368 |
| Model numbers | 802802203 |
Product
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Reason for recall
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
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-1649-2025. 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.