BEUDAMED
    FDA Recall Terminated

    ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

    Recall: Z-0563-2020 · Initiated November 8, 2016

    Recall

    Recall Number
    Z-0563-2020
    Event Number
    84180
    Firm
    Wright Medical Technology, Inc.
    FEI Number
    1043534
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 8, 2016
    Terminated
    November 3, 2020
    Address
    11576 Memphis Arlington Rd, Arlington, TN, 38002-9497

    Description

    ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

    Reason

    The firm discovered a lack of adequate documentation confirming sterility on certain products.

    Action

    The firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units.

    Distribution

    US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

    Quantity

    40 units