BEUDAMED
    FDA Recall Terminated

    Ultra Power Burs, Sterile, Single-Use.

    Recall: Z-0041-05 · Initiated August 26, 2004

    Recall

    Recall Number
    Z-0041-05
    Event Number
    29916
    Firm
    Linvatec Corp.
    FEI Number
    1017294
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 26, 2004
    Posted
    October 23, 2004
    Terminated
    July 6, 2012
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    Ultra Power Burs, Sterile, Single-Use.

    Reason

    The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.

    Action

    Each consignee will be notified by telephone, email, letter or UPS overnight delivery. They will be asked to return the affected product to Linvatec, Largo, Florida for credit or no-cost replacement. A returned goods authorization number will be assigned for the returned product.

    Distribution

    Distributed to 492 customers throughout the United States, and 301 customers internationally.

    Quantity

    58510 units