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Terminated

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

FDA Recall Z-0623-2016 · Posted 2016-01-08

Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2015-10-26
Date Terminated2016-06-23
Product Quantity262 units

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.

Firm Action

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

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063172ARTHROCARE CAVITY SPINEWANDArthrocare Corp. · 2007-04-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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