Device recall
Z-0111-2015: Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee…
FDA device recall · Class II · Signal Medical Corporation
Key facts
| Recall number (Z-number) | Z-0111-2015 |
|---|---|
| Recall event | 69420 |
| Product | Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75). |
| Product code | JWH |
| Recalling firm | Signal Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 14, 2016 |
| 510(k) numbers | K080199 |
| FEI number | 3002477077 |
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