OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of
FDA device recall Z-1312-06 · posted 2006-08-02 · Terminated
Recall details
- Recalling firm
- ArthroCare Corporation
- Reason for recall
- The product may lose sterility due to omission of the final pouch seal.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 198 units
- Distribution
- Nationwide.
- Date initiated
- 2006-06-28
- Date posted
- 2006-08-02
- Date terminated
- 2007-12-05
- 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 |