BEUDAMED
    FDA Recall Terminated

    Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)

    Recall: Z-0622-2018 · Initiated December 20, 2017

    Recall

    Recall Number
    Z-0622-2018
    Event Number
    78997
    Firm
    Medtronic Neurosurgery
    FEI Number
    3015531529
    Product Code
    HBO
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    December 20, 2017
    Terminated
    December 8, 2023
    Address
    125 Cremona Dr, Goleta, CA, 93117-3083

    Description

    Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)

    Reason

    Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

    Action

    A Consignee Notification with response form was sent to affected consignees on 12/20/2017.

    Distribution

    Algeria, Armenia, Australia, Canada, Cyprus, Egypt, Germany, Ghana, Greece, Guam, Iceland, Indonesia, Iran, Italy, Jordan, New Zealand, Poland, Portugal, Puerto Rica, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Swaziland, Sweden, Switzerland, Syria, Tunisia, Turkey, UAE, UK, USA, Yemen

    Quantity

    27,432.8 devices