Recall Z-1312-06 ยท KOG
ArthroCare Corporation
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.
| Date | Aug 2, 2006 (initiated Jun 28, 2006) |
| Status | Terminated |
| Reason | The product may lose sterility due to omission of the final pouch seal. |
| Root cause | Packaging process control |
| Action | The firm has issued notification letters to all customers in the United States on June 29, 2006 via overnight delivery, advising customers to return all product with incomplete or missing seals to Arthocare. |
| Quantity | 198 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022229 | SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 Opus Medical, Inc., Sep 6, 2002 |