Recall Z-1186-06 ยท KOG
ArthroCare Corporation
ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085
| Date | Jun 27, 2006 (initiated Jun 7, 2006) |
| Status | Terminated |
| Reason | Potential loss of product sterility due to breach of pouch seal. |
| Root cause | Packaging process control |
| Action | Notification letters were sent to all customers in the United States on June 7, 2006. All letters were sent via overnight delivery. |
| Distribution | Worldwide |
| 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 |