Biolox Option Taper Sleeve — Class II medical device recall Z-3132-2024
Ongoing recall by Zimmer GmbH, reported 2024-09-18, distributed nationwide. Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, howev
| Recall number | Z-3132-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer GmbH, Winterthur, Switzerland |
| Recall initiated | 2024-08-08 |
| Classified | 2024-09-12 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, NL |
| Quantity | 69 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00887868271489 |
| Lot numbers | 3185263 |
| Model numbers | 650-1066 |
Product
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
Reason for recall
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
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-3132-2024. 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.