BEUDAMED
    FDA Enforcement Class II Terminated

    Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

    Recall: Z-0223-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0223-2020
    Event ID
    83948
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2019
    Initiation Date
    September 16, 2019
    Classification Date
    October 28, 2019
    Termination Date
    April 24, 2020
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States

    Description

    Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

    Reason

    The subject product measures 4.0mm in diameter instead of 3.5mm.

    Code Info

    10L2702

    Distribution

    Distributed to NJ.

    Quantity

    6