FDA Device recall Z-1315-2021
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the f…
- FDA Device
- Class II
- terminated
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the f… by Depuy Orthopaedics, citing globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee A….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1315-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-22 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
Reason
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Identifiers
| code_info | Lot#: 9543538, Product Code: 129433130, GTIN 10603295025788 Lot#: 9553989, Product Code: 129433130, GTIN 1060329502578…Lot#: 9543538, Product Code: 129433130, GTIN 10603295025788 Lot#: 9553989, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554547, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554548, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554551, Product Code: 129433130, GTIN 10603295025788 Lot#: 9548774, Product Code: 129433140, GTIN 10603295025795 Lot#: 9548777, Product Code: 129433140, GTIN 10603295025795 Lot#: 9554569, Product Code: 129433140, GTIN 10603295025795 |
|---|
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-1315-2021%22
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