Z-0623-2016Class II

Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis...

Name: Z-0623-2016 Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis...
Creator: ArthroCare Corporation
Published: 2015-10-26
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2015-10-26 / Terminated / root cause: packaging

FDA source

ArthroCare Corporation began a recall of Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures on 2015-10-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0623-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-26
Posted: 2016-01-08
Terminated: 2016-06-23
Recalling firm: ArthroCare Corporation
Product: Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Affected consignees will be notified via letter beginning 11/2/15.
Quantity in commerce: 262 units
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.
Product codes and lots: Lot Numbers: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0623-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0623-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-08

Product code GEI

K063172Class IIArthrocare Cavity SpinewandArthrocare Corp. / cleared 2007-04-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)