Device recall
Z-0613-2012: OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer
FDA device recall · Class II · Innovatech Medical Resources L.P.
Key facts
| Recall number (Z-number) | Z-0613-2012 |
|---|---|
| Recall event | 60049 |
| Product | OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer |
| Product code | KOG |
| Recalling firm | Innovatech Medical Resources L.P. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2012 |
| 510(k) numbers | K070671 |
| FEI number | 3009124511 |
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