Recall Z-0623-2016 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ArthroCare Corporation
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
| Date | Jan 8, 2016 (initiated Oct 26, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Affected consignees will be notified via letter beginning 11/2/15. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063172 | ARTHROCARE CAVITY SPINEWAND Arthrocare Corp., Apr 27, 2007 |