Device recall
Z-0443-2012: "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE…
FDA device recall · Class II · Endotec, Inc.
Key facts
| Recall number (Z-number) | Z-0443-2012 |
|---|---|
| Recall event | 60138 |
| Product | "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Size… |
| Product code | NRA |
| Recalling firm | Endotec, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2013 |
| FEI number | 3004553437 |
At a glance
- None Linked 510(k)s
- 10–99 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