FDA Medical Device Recalls (openFDA)
Astora: MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
- Recall number
- Z-0279-2016
- Recalling firm
- Astora
- Product
- MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
- Status
- Terminated
- Initiated
- 2015-10-26
- Posted
- 2015-11-16
- Terminated
- 2016-03-09
- 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
- Lot, serial or model codes
- Lot number 936405. Serial numbers 936405001 through 936405056
- 510(k) numbers
- ["K121641"]
- PMA numbers
- not on file
- Product code
- PAH
- Firm FEI
- 3011770902
- Firm city
- Eden Prairie
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28