BEUDAMED
    FDA Enforcement Class II Terminated

    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.

    Recall: Z-0193-2018 · Reported December 13, 2017

    Enforcement

    Recall Number
    Z-0193-2018
    Event ID
    78501
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pro-Med Instruments Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 13, 2017
    Initiation Date
    November 2, 2017
    Classification Date
    December 5, 2017
    Termination Date
    July 11, 2018
    Address
    Botzinger Str. 38, N/A, Freiburg Im Breisgau, N/A, N/A, Germany

    Description

    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.

    Reason

    The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip.

    Code Info

    Lots: 17041 and 17272

    Distribution

    Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada

    Quantity

    1142 units