ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number: OM-8075; Product is distributed by Arthr
FDA device recall Z-1187-06 · posted 2006-06-27 · Terminated
Recall details
- Recalling firm
- ArthroCare Corporation
- Reason for recall
- Potential loss of product sterility due to breach of pouch seal.
- Action taken
- Notification letters were sent to all customers in the United States on June 7, 2006. All letters were sent via overnight delivery.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KOG
- Distribution
- Worldwide
- Date initiated
- 2006-06-07
- Date posted
- 2006-06-27
- Date terminated
- 2006-11-21
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 (K022229) | Opus Medical, Inc. | 2002-09-06 |