BEUDAMED
    FDA Enforcement Class II Terminated

    INBONE STEM, TIBIAL, TOP, Part Number 200011901

    Recall: Z-0565-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0565-2020
    Event ID
    84180
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2019
    Initiation Date
    November 8, 2016
    Classification Date
    November 25, 2019
    Termination Date
    November 3, 2020
    Address
    11576 Memphis Arlington Rd, Arlington, TN, 38002-9497, United States

    Description

    INBONE STEM, TIBIAL, TOP, Part Number 200011901

    Reason

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

    Code Info

    Lot Number 1540433

    Distribution

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

    Quantity

    65 units