Z-0279-2016Class II

MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed...

Name: Z-0279-2016 MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed...
Creator: Astora
Published: 2015-10-26
License: https://open.fda.gov/license/

Astora / initiated 2015-10-26 / Terminated / root cause: labeling and UDI

FDA source

Astora began a recall of MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence on 2015-10-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0279-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-26
Posted: 2015-11-16
Terminated: 2016-03-09
Recalling firm: Astora
Product: MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Product code: PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 52
Distribution: Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
Product codes and lots: Lot number 936405. Serial numbers 936405001 through 936405056

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0279-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0279-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-16

Product code PAH

K121641Class IIMiniarc Pro Single-Incision Sling SystemAmerican Medical Systems / cleared 2012-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)