Astora: Medical Device Recall in 2015 - (Recall #: Z-0279-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 26, 2015

Date Posted: November 25, 2015

Recall Number: Z-0279-2016

Event ID: 72552

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.

Status: Terminated

Product Quantity: 52

Code Information:

Lot number 936405. Serial numbers 936405001 through 936405056

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated