Device recall
Z-1816-2011: ASR UNI FEMORAL IMPL SIZE 63, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR…
FDA device recall · Class II · Depuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-1816-2011 |
|---|---|
| Recall event | 57177 |
| Product | ASR UNI FEMORAL IMPL SIZE 63, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component 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