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Recall Observatory FDA recall evidence

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

October 26, 2015

Class II

Product summary

Firm
ArthroCare Corporation
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

    reason.no_named_rule · v1.0.0

    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.