BEUDAMED
    FDA Recall Terminated

    IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.

    Recall: Z-1704-2009 · Initiated January 22, 2009

    Recall

    Recall Number
    Z-1704-2009
    Event Number
    52177
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 22, 2009
    Posted
    August 4, 2009
    Terminated
    August 18, 2011
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.

    Reason

    Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.

    Action

    Urgent Medical Device Recall letter dated January 23, 2009. All affected Smith & Nephew Sales Representatives, Distributors and Hospitals were notified of problem and the recall via Fed Ex and e-mail on 01/22/2009. They were instructed to immediately check their inventory and return the product.

    Distribution

    Distribution to USA, Switzerland and Australia.

    Quantity

    99 units