Device recall
Z-3099-2011: PFC Sigma Round Dome Patella 38 MM 3 Peg Device is indicated for use in knee…
FDA device recall · Class II · DePuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-3099-2011 |
|---|---|
| Recall event | 59238 |
| Product | PFC Sigma Round Dome Patella 38 MM 3 Peg Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cement. |
| Product code | JWH |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2013 |
| 510(k) numbers | K884796 |
| 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