BEUDAMED
    FDA Enforcement Class II Ongoing

    VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

    Recall: Z-0728-2023 · Reported December 28, 2022

    Enforcement

    Recall Number
    Z-0728-2023
    Event ID
    91174
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Icotec Ag
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 28, 2022
    Initiation Date
    November 3, 2022
    Classification Date
    December 19, 2022
    Address
    Industriestrasse 12, Altstatten Sg, N/A, Switzerland

    Description

    VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

    Reason

    During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.

    Code Info

    UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045

    Distribution

    US Nationwide distribution in the state of GA.

    Quantity

    6 devices