BEUDAMED
    FDA Enforcement Class II Terminated

    Tapered SwissPlus Implant System, Model No. SPB10

    Recall: Z-1823-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1823-2017
    Event ID
    76746
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    March 20, 2017
    Classification Date
    April 14, 2017
    Termination Date
    November 1, 2017
    Address
    1900 Aston Ave, N/A, Carlsbad, CA, 92008-7308, United States

    Description

    Tapered SwissPlus Implant System, Model No. SPB10

    Reason

    It was manufactured with the minor diameter of the internal thread that is below specification.

    Code Info

    Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731

    Distribution

    Worldwide: ZA, FR, IT, IR

    Quantity

    188 units