Device product
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Z-0279-2016
Product summary
- Firm
- Astora
- Event
- Event 72552
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52
- Official record key
device-enforcement:Z-0279-2016
Official wording
Reason: 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.
Code information: Lot number 936405. Serial numbers 936405001 through 936405056
Distribution pattern: Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
Derived failure modes
-
Unknown
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.