Z-0279-2016 Class II Terminated
FDA device recall Z-0279-2016 was initiated by Astora on October 26, 2015 and is designated Class II. Reason for recall: The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical… The recall status is terminated (terminated March 9, 2016). Affected quantity: 52.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2015
- Initiation Date
- October 26, 2015
- Termination Date
- March 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52
Product Description
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Reason for Recall
The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
Distribution Pattern
Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
Code Information
Lot number 936405. Serial numbers 936405001 through 936405056