Device recall
Z-1316-05: Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref…
FDA device recall · Class II · Depuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-1316-05 |
|---|---|
| Recall event | 32192 |
| Product | Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352. |
| Product code | JWH |
| Recalling firm | Depuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2005 |
| 510(k) numbers | K961685 |
| FEI number | 1818910 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 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