Device product
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
Z-0623-2016
Product summary
- Event
- Event 72789
- Status
- Terminated
- Classification
- Class II
- Quantity
- 262 units
- Official record key
device-enforcement:Z-0623-2016
Official wording
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.
Code information: Lot Numbers: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.