FDA Device recall Z-1103-2021
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products
- FDA Device
- Class II
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products by Depuy Orthopaedics, citing the taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1103-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-08 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Reason
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Identifiers
| code_info | Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1103-2021%22
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