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U.S. Department of Health and Human Services

Class 2 Device Recall Pinnacle Pelvic Floor Repair KitAnterior/Apical, and Pinnacle Pelvic Floor Repair KitPosterior

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  Class 2 Device Recall Pinnacle Pelvic Floor Repair KitAnterior/Apical, and Pinnacle Pelvic Floor Repair KitPosterior see related information
Date Initiated by Firm May 10, 2011
Date Posting Updated August 03, 2011
Recall Status1 Terminated 3 on November 15, 2011
Recall Number Z-2931-2011
Recall Event ID 58852
510(K)Number K071957  
Product Classification Surgical Mesh (Polymeric) - Product Code FTL
Product Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE.
Boston Scientific, Corp.

Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Code Information Catalog/UPC: M0068317100, Lot: 1ML0072001. Catalog/UPC M0068317050, Lot: 1ML0070801.
Recalling Firm/
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Cindy Finney
Manufacturer Reason
for Recall
The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.
FDA Determined
Cause 2
Device Design
Action Boston Scientific Corporation sent on May 10, 2011 an "URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED" letter to all affected customers. The letter included; reason for recall, instructions for the quarantine, discontinued use, and return of the devices, and information for Medwatch reporting. The letter also includes a form that is to be faxed to the firm. For information call (508) 683-4678.
Quantity in Commerce 540
Distribution Worldwide Distribution; (USA) Nationwide distribution, and the countries of Puerto Rico, France, Great Britain, Ireland, Italy, Spain, Sweden, Canada, and Australia.
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 = FTL and Original Applicant = BOSTON SCIENTIFIC CORP.