Device recall
Z-0610-2012: OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with…
FDA device recall · Class II · Innovatech Medical Resources L.P.
Key facts
| Recall number (Z-number) | Z-0610-2012 |
|---|---|
| Recall event | 60049 |
| Product | OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502 Intended for rotator cuff repair |
| Product code | MBI |
| Recalling firm | Innovatech Medical Resources L.P. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2012 |
| 510(k) numbers | K083240 |
| 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