BEUDAMED
    FDA Enforcement Class II Terminated

    Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662

    Recall: Z-2214-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2214-2013
    Event ID
    66098
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ebi, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2013
    Initiation Date
    August 13, 2013
    Classification Date
    September 17, 2013
    Termination Date
    March 11, 2015
    Address
    100 Interpace Pkwy, N/A, Parsippany, NJ, 07054-1149, United States

    Description

    Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662

    Reason

    Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.

    Code Info

    14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT0022 IT0023 14-501662 Counter Torque Lots IT0020 IT0021

    Distribution

    Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.

    Quantity

    427 units