ArthroCare Corporation recalls Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood ves

Recalled January 20, 2016 · FDA recall Z-0623-2016 · ArthroCare

Hazard

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. · FDA Class II

Units

262 units

Sold at

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.

Description

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.

Product

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

Manufacturer(s)

ArthroCare Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →