BEUDAMED
    FDA Recall Terminated

    PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer

    Recall: Z-0960-2009 · Initiated November 21, 2008

    Recall

    Recall Number
    Z-0960-2009
    Event Number
    50545
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 21, 2008
    Posted
    February 3, 2009
    Terminated
    November 27, 2012
    Address
    1450 Brooks Rd, Memphis, TN, 38116

    Description

    PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer

    Reason

    The product was breaking during use.

    Action

    All affected Smith & Nephew International Distributors were notified via email on 11/21/2008. They were instructed to immediately notify their accounts concerning the recall. Contact Smith & Nephew Inc at 901-399-6771 for assistance.

    Distribution

    Germany, France, Italy Austria, Switzerland, Belgium, United Kingdom, Greece, Australia, South Africa, Spain, and Cypress

    Quantity

    159 units