BEUDAMED
    FDA Recall Terminated

    Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.

    Recall: Z-2027-2009 · Initiated January 23, 2009

    Recall

    Recall Number
    Z-2027-2009
    Event Number
    52617
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    JDW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 23, 2009
    Posted
    September 15, 2009
    Terminated
    July 29, 2013
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.

    Reason

    Hinge failure: The product is cracking or breaking during use.

    Action

    The Smith & Nephew Sales Representatives were notified of the problem and the recall via certified letter and e-mail on 01/23/2009. A second notice was sent to the hospitals on 06/06/2009. All affected Smith & Nephew International Distributors were notified via email on 01/23/2009. They were instructed to immediately notify their accounts concerning the recall. Smith & Nephew c/o Return Goods, 4287 Delp St, Memphis, TN 38118

    Distribution

    Worldwide Distribution: USA, Turkey, Denmark, Germany, Malaysia, Hong Kong, Korea, Switzerland, Japan, Singapore, Canada, New Zealand, Australia, and Italy.

    Quantity

    7,089 units