BEUDAMED
    FDA Recall Terminated

    QuickGraft Model # 430PST

    Recall: Z-2548-2019 · Initiated August 15, 2019

    Recall

    Recall Number
    Z-2548-2019
    Event Number
    83644
    Firm
    Musculoskeletal Transplant Foundation, Inc.
    FEI Number
    3001236616
    Product Code
    GAT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 15, 2019
    Terminated
    July 1, 2020
    Address
    125 May St, Ste 300, Edison, NJ, 08837-3264

    Description

    QuickGraft Model # 430PST

    Reason

    Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.

    Action

    You may choose to add the additional label to the unit(s), this may be completed by an appropriate Sales Representative or hospital staff. Or, you may choose to have the unit(s) returned to MTF for the labelling correction

    Distribution

    NY NC LA TX MO OH

    Quantity

    9 Qty