Device recall
Z-2422-2008: Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R…
FDA device recall · Class II · Zimmer Inc.
Key facts
| Recall number (Z-number) | Z-2422-2008 |
|---|---|
| Recall event | 49079 |
| Product | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R, Zimmer, Winterthur, Switzerland; REF 01.00214.158. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement) |
| Product code | KWA |
| Recalling firm | Zimmer Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2009 |
| 510(k) numbers | K053536 |
| FEI number | 1000220733 |
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