ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
FDA device recall Z-1952-2011 · posted 2011-04-12 · Terminated
Recall details
- Recalling firm
- ArthroCare Corporation
- Reason for recall
- During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.
- Action taken
- On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 170 units
- Distribution
- Product was released for distribution in US.
- Date initiated
- 2010-09-30
- Date posted
- 2011-04-12
- Date terminated
- 2011-08-01
- 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 |
|---|---|---|
| OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE (K090615) | Arthrocare Corp. | 2009-06-03 |