Class 2 Device Recall MiniArc Pro Single incision Sling System

• Date Initiated by Firm: October 26, 2015
• Date Posted: November 16, 2015
• Recall Status: Terminated on March 09, 2016
• Recall Number: Z-0279-2016
• Recall Event ID: 72552
• 510(K)Number: K121641
• Product Classification: mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling - Product Code PAH
• Product: MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
• Code Information: Lot number 936405. Serial numbers 936405001 through 936405056
• Recalling Firm/ Manufacturer: Astora; 13200 Pioneer Trl; Eden Prairie MN 55347-4119
• For Additional Information Contact: ASTORA Womens Health Customer Service ; 844-879-0787
• Manufacturer 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.
• FDA Determined Cause: Labeling mix-ups
• Action: Consignees were hand delivered by sales representatives a Astora Women's Health "Urgent Recall Notice". The letter was addressed to Physician, Health Care Professional, Nurse & Risk Manager. The letter described the problem and the product involved in the recall. Consignees were advised to check their inventory and return all affected product, notify those that might be affected and to complete and return the Acknowledgement Form. For questions contact ASTORA Women's Health Customer Service at 1-844-879-0787.
• Quantity in Commerce: 52
• Distribution: Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PAH and Original Applicant = AMERICAN MEDICAL SYSTEMS