Device recall
Z-0611-2012: OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in…
FDA device recall · Class II · Innovatech Medical Resources L.P.
Key facts
| Recall number (Z-number) | Z-0611-2012 |
|---|---|
| Recall event | 60049 |
| Product | OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. |
| Product code | GAT |
| Recalling firm | Innovatech Medical Resources L.P. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2012 |
| 510(k) numbers | K042031 |
| FEI number | 3009124511 |
At a glance
- 1–9 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