Drug recall
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar…
FDA recall event 87433 · Class II · DePuy Orthopaedics, Inc.
Key facts
| Event ID | 87433 |
|---|---|
| Recall numbers | Z-1314-2021, Z-1315-2021, Z-1316-2021 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Product type | Devices |
| Products | ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral…, The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint., 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Feb 22, 2021 |
| Report date | Apr 7, 2021 |
| Termination date | Oct 11, 2023 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1818910 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: