BEUDAMED
    FDA Enforcement Class II Terminated

    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.

    Recall: Z-2751-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2751-2016
    Event ID
    74798
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Microfixation, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2016
    Initiation Date
    June 13, 2016
    Classification Date
    September 8, 2016
    Termination Date
    August 21, 2019
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480, United States

    Description

    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.

    Reason

    Potential sterility deficiency.

    Code Info

    Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016

    Distribution

    Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa.

    Quantity

    54 units