Device recall
Z-0614-2012: OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be…
FDA device recall · Class II · Innovatech Medical Resources L.P.
Key facts
| Recall number (Z-number) | Z-0614-2012 |
|---|---|
| Recall event | 60049 |
| Product | OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft tissue to bones |
| Product code | MBI |
| Recalling firm | Innovatech Medical Resources L.P. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2012 |
| 510(k) numbers | K101448 |
| 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