Recall Z-1321-2016— ArthroCare Corporation
Class II · Terminated
Class II FDA medical device recall by ArthroCare Corporation, initiated 2016-03-03, terminated 2017-05-17. It names one FDA 510(k) clearance: K080282. Product: TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01. Reason: During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels..
- Recalling firm
- ArthroCare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-03
- Terminated
- 2017-05-17
- 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
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
Reason for recall
During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.
Data sourced from openFDA. This site is unofficial and independent of the FDA.