FDA Medical Device Recalls (openFDA)
ArthroCare Corporation: Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
- Recall number
- Z-0623-2016
- 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.
- Status
- Terminated
- Initiated
- 2015-10-26
- Posted
- 2016-01-08
- Terminated
- 2016-06-23
- 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.
- Root cause
- Under Investigation by firm
- Action
- Affected consignees will be notified via letter beginning 11/2/15.
- Quantity
- 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.
- Lot, serial or model codes
- Lot Numbers: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328
- 510(k) numbers
- ["K063172"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3010813691
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28