BEUDAMED
    FDA Enforcement Class II Terminated

    QuickGraft¿ Model # 430PST

    Recall: Z-2548-2019 · Reported October 2, 2019

    Enforcement

    Recall Number
    Z-2548-2019
    Event ID
    83644
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Musculoskeletal Transplant Foundation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2019
    Initiation Date
    August 15, 2019
    Classification Date
    September 20, 2019
    Termination Date
    July 1, 2020
    Address
    125 May St Ste 300, Edison, NJ, 08837-3264, United States

    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.

    Code Info

    Serial # 00319004921075 00319004921073 00319007681048 00319014411085 00618052231059 03319006511040 03319009191029 03319019231072 03519018121056

    Distribution

    NY NC LA TX MO OH

    Quantity

    9 Qty