ClearanceBrief
Recall Z-0261-06 ยท GAD Retractor

Boston Scientific Corporation

Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture (contains 1 Product Code 820-175) Product Code: 820-171

DateDec 1, 2005 (initiated Oct 25, 2005)
StatusTerminated
ReasonSterility of device compromised due to breach in packaging
Root causeOther
ActionBoston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.
Quantity119
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.