BEUDAMED
    FDA Recall Terminated

    Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500

    Recall: Z-1234-2020 · Initiated November 11, 2019

    Recall

    Recall Number
    Z-1234-2020
    Event Number
    84765
    FEI Number
    1000432246
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 11, 2019
    Terminated
    October 14, 2020
    Address
    Medicrea International 5389 Route De Strasbourg Vancia Rillieux La Pape France

    Description

    Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500

    Reason

    Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)

    Action

    Medicrea issued notification dated 11/11/19 via email, stating reason for recall, health risk and action to take: 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA. 2. Circulate this Field Safety Notice internally to all interested/affected parties. 3. Inform MEDICREA if any of the subject devices have been distributed to other organizations. inform MEDICREA of any adverse events concerning the use of the subject devices. Complete the attached customer response form. contact person for this action is given below: Karine TROGNEUX-MEDICREA INTERNATIONAL Regulatory Affairs Manager Direct : +33(0)4.69.85.95.39 Standard : +33 (0)4.72.01.87.87. Fax - N +33 (0)04 72 01 87 88 Mail : [email protected]

    Distribution

    CA, FL

    Quantity

    3 units