Device recall
Z-0930-2012: The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools…
FDA device recall · Class II · DePuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-0930-2012 |
|---|---|
| Recall event | 60320 |
| Product | The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of the PFC SIGMA Knee. SIGMA HP Fixed Bearing Tibial Tray Impactors Packaged in poly bag with optional protection from sharp or fragile points, distributed by DePuy International… |
| Product code | HWA |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 12, 2013 |
| FEI number | 1818910 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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