Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood ves
FDA device recall Z-0623-2016 · posted 2016-01-08 · Terminated
Recall details
- Recalling firm
- ArthroCare Corporation
- Reason for recall
- There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier.
- Action taken
- Affected consignees will be notified via letter beginning 11/2/15.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 262 units
- Distribution
- Worldwide distribution. US nationwide including OH, MO, AZ, AL, CA, FL, SC, GA, and PA; Spain, France, United Kingdom, Germany, Switzerland, Singapore, Russia, Turkey, and Ecuador.
- Date initiated
- 2015-10-26
- Date posted
- 2016-01-08
- Date terminated
- 2016-06-23
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTHROCARE CAVITY SPINEWAND (K063172) | Arthrocare Corp. | 2007-04-27 |