Device recall
Z-0438-2012: "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE…
FDA device recall · Class II · Endotec, Inc.
Key facts
| Recall number (Z-number) | Z-0438-2012 |
|---|---|
| Recall event | 60138 |
| Product | "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X5 CAT 04-63-2123; SIZE 3-4X5 CAT 04-63-2124; SIZE 3-5X5 CAT 04-63-2125; SIZE 3-6X5 CAT 04-63-2126… |
| 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