Device recall
Z-1686-2009: DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component…
FDA device recall · Class II · Depuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-1686-2009 |
|---|---|
| Recall event | 52088 |
| Product | DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The device is used for total or unicompartmental knee arthroplasty and is intended to provide increased patient mobility and… |
| Product code | JWH |
| Recalling firm | Depuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2010 |
| 510(k) numbers | K943462 |
| FEI number | 1818910 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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