ArthroCare Corporation: Medical Device Recall in 2016 - (Recall #: Z-0623-2016)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2016.
Data Source: FDA.
Product Description:
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
Product Classification:
Class II
Date Initiated: October 26, 2015
Date Posted: January 20, 2016
Recall Number: Z-0623-2016
Event ID: 72789
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.
Status: Terminated
Product Quantity: 262 units
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.
Voluntary or Mandated:
Voluntary: Firm initiated