BEUDAMED
    FDA Recall 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 · Initiated June 13, 2016

    Recall

    Recall Number
    Z-2751-2016
    Event Number
    74798
    Firm
    Biomet Microfixation, LLC
    FEI Number
    1032347
    Product Code
    KKY
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 13, 2016
    Terminated
    August 21, 2019
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    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.

    Action

    Zimmer Biomet Customers were sent an Urgent Product Recall letter dated June 13, 2016, via via FedEx mail. The letter notified customers of a recall of Hard Tissue Replacement Polymer Implants due to voids in sterile packaging. The firm instructed customers to locate and discontinue use of the implants, complete the Fax Response form and fax it to 904-741-9425, send back any quarantined product using the FedEx labels provided along with the recall notification, and to notify facilities where the implant was further distributed by forwarding them a copy of the provided notice. The firm instructed distributors to forward the notice to officials of their customers who are in charge of receiving recall notices. Additionally, the firm informed distributors that they are responsible for locating and returning distributed product. Questions are to be directed to 1-800-874-7711 or 904-741-4400 x9574, Monday thru Friday from 8am to 4pm ET. Her after hours phone is 812-614-9499. For questions regarding this recall call 904-741-9225.

    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