BEUDAMED
    FDA Recall Terminated

    TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057

    Recall: Z-0350-2017 · Initiated August 29, 2016

    Recall

    Recall Number
    Z-0350-2017
    Event Number
    75283
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    KWY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 29, 2016
    Terminated
    August 16, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057

    Reason

    Some Bipolar shells were manufactured with an out of specification retainer groove.

    Action

    The firm initiated their recall by FedEx and Email on 08/29/2016 to hospitals and distributors and requested the return of any in stock product. International consignees were notified by Email on 08/29/2016. Additionally, the firm notified the US physician of the issue by overnight letter on 09/08/2016.

    Distribution

    Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates

    Quantity

    2352 units