BEUDAMED
    FDA Recall Terminated

    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)

    Recall: Z-1911-2017 · Initiated March 30, 2017

    Recall

    Recall Number
    Z-1911-2017
    Event Number
    76943
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    KDG
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 30, 2017
    Terminated
    August 21, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)

    Reason

    The stability data does not support the product labeled with a 10-year shelf life.

    Action

    The firm initiated their recall by email and letter on 03/30/2017. Consignees were asked to inspect inventory to locate and quarantine affected product. All consignees are asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew.

    Distribution

    Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

    Quantity

    1126 units