Device recall
Z-1621-2010: Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented…
FDA device recall · Class II · Endotec, Inc.
Key facts
| Recall number (Z-number) | Z-1621-2010 |
|---|---|
| Recall event | 52527 |
| Product | Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Titanium Alloy, Sterilized, (Beuchel-Pappas (BP)) The B-P Knee Replacement System is composed of several components used to provide surgeons with different intra-operative options. All metallic… |
| Product code | JWH |
| Recalling firm | Endotec, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 22, 2013 |
| 510(k) numbers | K012702 |
| FEI number | 3004553437 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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