ArthroCare Cavity 8 Gauge Spine Wand Recalled for Sterile Barrier Failure
ArthroCare Corporation is recalling 262 Cavity 8 Gauge Spine Wands because cracking in the tray compromises the sterile barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a compromised sterile barrier, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
ArthroCare Corporation is recalling 262 units of the Cavity 8 Gauge Spine Wand. This medical device is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures. The recall is due to a manufacturing defect where the tray cracks when the device is snapped into place.
The crack extends through the full thickness of the tray, which compromises the sterile barrier. This defect poses a risk of contamination to the device and potentially to patients during spinal procedures. The affected units were distributed worldwide, including in the United States and various international markets.
Healthcare providers and consumers should stop using the recalled Cavity 8 Gauge Spine Wands immediately. Affected lot numbers include 1024313, 1024482, 1027160, 1034306, 1041879, and 1059328. Users should contact ArthroCare Corporation for instructions on returning or replacing the devices.
The recalled product
- Product
- Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
- Manufacturer
- ArthroCare Corporation
- Affected units
- 262
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Numbers: 1024313
- 1024482
- 1027160
- 1034306
- 1041879
- 1059328
Distribution
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