Recall Z-0279-2016 ยท PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Astora
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
| Date | Nov 16, 2015 (initiated Oct 26, 2015) |
| Status | Terminated |
| 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. |
| Root 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 | 52 |
| Distribution | Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM American Medical Systems, Sep 7, 2012 |