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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 Recall
Pinnacle Pelvic Floor Repair KitAnterior/Apical, and Pinnacle Pelvic Floor Repair KitPosterior
see related information
Date Posted August 03, 2011
Recall Status1 Terminated on November 15, 2011
Recall Number Z-2931-2011
Recall Event ID 58852
Premarket Notification
510(K) Number
K071957 
Product Classification Mesh, Surgical, 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/
Manufacturer
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, Massachusetts 01752-1234
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Cindy Finney
508-683-4678
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = BOSTON SCIENTIFIC CORP.
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