MiniArc Pro Single incision Sling System — Class II medical device recall Z-0279-2016
Terminated recall by Astora, reported 2015-11-25, distributed in AZ, CA, DE, IL, KS, NE, NJ, NY…. The lot number on the outer carton label did not match the lot number printed on the tray label or identificat
| Recall number | Z-0279-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Astora, Eden Prairie, MN, United States |
| Recall initiated | 2015-10-26 |
| Classified | 2015-11-16 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2016-03-09 |
| Distributed | AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX |
| Quantity | 52 |
| Reason classes | labeling |
| Lot numbers | 936405, 936405XXX |
| Serial numbers | 936405001 |
Product
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0279-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.