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Astora recalls MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat fe
Recalled November 25, 2015 · FDA recall Z-0279-2016 · Astora
Hazard
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. · FDA Class II
Units
52
Sold at
Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
Description
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.
Product
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Manufacturer(s)
Astora
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →