Z-0623-2016 Class II Terminated
FDA device recall Z-0623-2016 was initiated by ArthroCare Corporation on October 26, 2015 and is designated Class II. 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. The recall status is terminated (terminated June 23, 2016). Affected quantity: 262 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2016
- Initiation Date
- October 26, 2015
- Termination Date
- June 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 262 units
Product Description
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
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.
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.
Code Information
Lot Numbers: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328