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

Recall date

October 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0623-2016

FDA classification

Class II

Brand / firm

ArthroCare Corporation

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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