BEUDAMED
    FDA Recall Terminated

    Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.

    Recall: Z-1448-2014 · Initiated February 7, 2014

    Recall

    Recall Number
    Z-1448-2014
    Event Number
    67675
    Firm
    Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada
    FEI Number
    3000327445
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 7, 2014
    Posted
    April 10, 2014
    Terminated
    April 23, 2014

    Description

    Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.

    Reason

    The Male Components in this lot are made of material with lower strength than manufacturing specifications.

    Action

    Pega Medical sent an Urgent Field Safety Notice-Recall letter dated February 7, 2014, to their customers via email. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to identify the affected devicee, verify if it was used in a patient and place the affected device in quarantine immediately if not used. If not used, return the affected device to Pega Medical Inc. to the address provided. Pega's customer notification stated "If used, it is recommended to continue the normal patient follow up. Customers with questions should call (450) 688-5144 ext. 242 or email [email protected]

    Distribution

    Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.

    Quantity

    Total of 5 units (2 units in the US and 3 units in Germany)