BEUDAMED
    FDA Recall Terminated

    Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.

    Recall: Z-1546-2015 · Initiated April 10, 2015

    Recall

    Recall Number
    Z-1546-2015
    Event Number
    71061
    Firm
    Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada
    FEI Number
    3000327445
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 10, 2015
    Posted
    April 29, 2015
    Terminated
    June 29, 2015

    Description

    Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.

    Reason

    The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.

    Action

    The firm sent the Urgent Field Safety Notice-Recall letter, dated April 10, 2015 to consignees via email. The letter listed the affected product as FEMALE DRIVER FASSIER-DUVAL IM TELESCOPIC SYSTEM. Consignees are requested to return devices back to the firm for disposal. Consignees with questions should contact the firm at 450-688-5144 ext. 242 or send email to [email protected]

    Distribution

    Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.

    Quantity

    9 units (5 units in the US and 4 units international)