FDA-Device2015-11-25Class II
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Astora
Hazard
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.
Sold states
Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
Affected count
52
Manufactured in
13200 Pioneer Trl, N/A, Eden Prairie, MN, United States
Products
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0279-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief