RecallDepth

Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.

Company
Arthrocare Corporation
Recall Initiated
October 26, 2015
Posted
January 8, 2016
Terminated
June 23, 2016
Recall Number
Z-0623-2016
Quantity
262 units
Firm Location
Austin, TX

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

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.

Lot / Code Info

Lot Numbers: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328

Root Cause

Under Investigation by firm

Action Taken

Affected consignees will be notified via letter beginning 11/2/15.

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