BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2931-2011 · Initiated May 10, 2011

    Recall

    Recall Number
    Z-2931-2011
    Event Number
    58852
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 10, 2011
    Posted
    August 3, 2011
    Terminated
    November 15, 2011
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    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.

    Reason

    The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.

    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.

    Distribution

    Worldwide Distribution; (USA) Nationwide distribution, and the countries of Puerto Rico, France, Great Britain, Ireland, Italy, Spain, Sweden, Canada, and Australia.

    Quantity

    540