Device recall
Z-1806-2011: ASR 300 Size 66, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular…
FDA device recall · Class II · Depuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-1806-2011 |
|---|---|
| Recall event | 57177 |
| Product | ASR 300 Size 66, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup components are part of a system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup… |
| Product code | KWA |
| Recalling firm | Depuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 29, 2013 |
| 510(k) numbers | K080991 |
| FEI number | 1818910 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database