Class 2 Device Recall Vesica

• Date Initiated by Firm: June 02, 2006
• Date Posted: August 02, 2006
• Recall Status: Terminated on April 17, 2007
• Recall Number: Z-1308-06
• Recall Event ID: 35724
• 510(K)Number: K932925
• Product Classification: Staple, Fixation, Bone - Product Code JDR
• Product: Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000).
• Code Information: Lots 8555778, 8552615 and 8718072.
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 780 Brookside Dr; Spencer IN 47460-1080
• For Additional Information Contact: 508-683-4186
• Manufacturer Reason for Recall: The packages are labeled sterile, but the product was not sterilized.
• FDA Determined Cause: Other
• Action: Consignees were notified by letters dated 6/2/06 and sent via Federal Express and requesting return of the products.
• Quantity in Commerce: 22 kits.
• Distribution: Nationwide, including California, Florida, Kansas, North Carolina, Oklahoma, South Dakota, Tennessee, West Virginia and Wisconsin.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JDR and Original Applicant = VESITEC MEDICAL, INC.