Device recall
Z-1312-06: OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS…
FDA device recall · Class II · ArthroCare Corporation
Key facts
| Recall number (Z-number) | Z-1312-06 |
|---|---|
| Recall event | 35878 |
| Product | OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of sutures through soft tissue in endoscopic and other limited access procedures. |
| Product code | KOG |
| Recalling firm | ArthroCare Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2007 |
| 510(k) numbers | K022229 |
| FEI number | 3010813691 |
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