Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
Reported: January 20, 2016 Initiated: October 26, 2015 #Z-0623-2016
Product Description
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
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.
Details
- Recalling Firm
- ArthroCare Corporation
- Units Affected
- 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.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.. Recalled by ArthroCare Corporation. Units affected: 262 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2016. Severity: Moderate. Recall number: Z-0623-2016.
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