FDA Device recall Z-0279-2016
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx by Astora, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0279-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-26 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Astora |
| Distribution | AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX |
Product
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
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.
Identifiers
| code_info | Lot number 936405. Serial numbers 936405001 through 936405056 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0279-2016%22
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