Recall Z-0279-2016— Astora
Class II · Terminated
Class II FDA medical device recall by Astora, initiated 2015-10-26, terminated 2016-03-09. It names one FDA 510(k) clearance: K121641. 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..
- Recalling firm
- Astora
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-26
- Terminated
- 2016-03-09
- Firm location
- Eden Prairie, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.