BEUDAMED
    FDA Recall Terminated

    Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30

    Recall: Z-1688-2019 · Initiated April 26, 2019

    Recall

    Recall Number
    Z-1688-2019
    Event Number
    82759
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    April 26, 2019
    Terminated
    April 22, 2021
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30

    Reason

    The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.

    Action

    The firm initiated the recall on 04/26/2019 by electronic mail. The notice requested the consignee cease distribution of the product, notify their customers (the user), quarantine all units subject to recall in inventory, and if any units were implanted to follow-up on the patient's condition 30 days after surgery.

    Distribution

    OK, VA, FL

    Quantity

    2 units