Universal Femoral Sleeves — Class II medical device recall Z-1103-2021
Terminated recall by DePuy Orthopaedics, Inc., reported 2021-02-17, distributed nationwide. The taper dimensions may be out of specification due to a production issue during the manufacturing of these l
| Recall number | Z-1103-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2021-01-08 |
| Classified | 2021-02-09 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2024-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, CN, DE |
| Quantity | 60 sleeves |
| Reason classes | specification failure |
| Lot numbers | J85Y90, J85Y92, J86T20, J86T23, J8790J |
Product
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Reason for recall
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
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-1103-2021. 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.