Astora recalls MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat fe…

Recall date

October 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0279-2016

FDA classification

Class II

Brand / firm

Astora

Sold / distributed

Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.