BEUDAMED
    FDA Enforcement Class II 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 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0622-2018
    Event ID
    78997
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neurosurgery
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    December 20, 2017
    Classification Date
    February 15, 2018
    Termination Date
    December 8, 2023
    Address
    125 Cremona Dr, Goleta, CA, 93117-3083, United States

    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.

    Code Info

    Affected Lots: D80412, D84100, E00008, E00983, E03049, E03716, E05806, E07257, E09145, E14782, E14896, E15195, E19181, E19182, E19183, E19184, E19868, E20599, E23631, E33102, D80413, D84101, E00009, E00984, E03050, E03717, E05233, E05807, E07258, E09117, E09146, E09239, E11242, E11243, E11244, E11706, E12011, E12012, E13574, E14784, E14898, E15197, E19185, E19186, E19187, E19188, E19869, E20600, E23768, E23769, E23770, E23771, E23772, E23773, E23774, E33103, E33104, E33105, E33106, E33107, E33108, E33109, E33110, E33454, E34928, E05810, E09149, E19194, E19871, E23775, E33099

    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