BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.

    Recall: Z-1811-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1811-2014
    Event ID
    68526
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ebi, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    May 15, 2014
    Classification Date
    June 17, 2014
    Termination Date
    April 21, 2017
    Address
    399 Jefferson Rd, N/A, Parsippany, NJ, 07054-3707, United States

    Description

    Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.

    Reason

    The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.

    Code Info

    Catalog Number 14-501669; Lot Number 006731

    Distribution

    Worldwide Distribution - USA (nationwide) and the country The Netherlands.

    Quantity

    32 units (30 domestic and 2 international)