Cavity 8 Gauge Spine Wand indicated for resection recall: Sterility Concern
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
Why was Cavity 8 Gauge Spine Wand indicated for resection 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328
- Product
- Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
- Recalling firm
- ArthroCare Corporation
- 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.
- Recall date
- January 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)