Recall Z-0623-2016— ArthroCare Corporation
Class II · Terminated
Class II FDA medical device recall by ArthroCare Corporation, initiated 2015-10-26, terminated 2016-06-23. It names one FDA 510(k) clearance: K063172. Product: Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.. 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..
- Recalling firm
- ArthroCare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-26
- Terminated
- 2016-06-23
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.