BEUDAMED
    FDA Recall Terminated

    Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001

    Recall: Z-1500-06 · Initiated May 17, 2006

    Recall

    Recall Number
    Z-1500-06
    Event Number
    35828
    Firm
    Xiros Plc 28-30 Blenheim Terrace Leeds United Kingdom
    FEI Number
    3013299874
    Product Code
    HXJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 17, 2006
    Posted
    September 13, 2006
    Terminated
    September 14, 2012

    Description

    Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001

    Reason

    The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.

    Action

    Customer recall notifications included: a) Telephone notification to highest volume users b) Recall letters were sent via certified mail to all customers June 1, 2006. Customers were instructed to cease using immediately and return the Impactors to Tapco. The customers were instructed to call the firm for a return authorization number. Modified loaner Impactors will be made available to customers as soon as possible.

    Distribution

    Nationwide & Worldwide, including Spain, Japan, UAE, Italy, Germany

    Quantity

    89