BEUDAMED
    FDA Enforcement Class II Terminated

    SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery

    Recall: Z-0270-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0270-2020
    Event ID
    84017
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pega Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 13, 2019
    Initiation Date
    October 2, 2019
    Classification Date
    November 1, 2019
    Termination Date
    October 26, 2020
    Address
    1111 Chomedey (A-13) E, N/A, Laval, N/A, N/A, Canada

    Description

    SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery

    Reason

    There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.

    Code Info

    Catalogue Numbers: SCF-KNB265, SCF-KNB273, SCF-KNB365, SCF-KNB373; Lot Numbers: 160428-03, 160428-04, A182-05, A182-15, 160603-05, 160603-06, A183-06

    Distribution

    Nationwide distribution to CA, FL, GA, HI, LA, MA, MO, NC, NY, OK. International distribution to AUSTRALIA, CANADA, DENMARK, GERMANY, ISRAEL, MEXICO, ROMANIA, RUSSIA, UNITED ARAB EMIRATES, UNITED KINGDOM

    Quantity

    31 devices