BEUDAMED
    FDA Recall 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 · Initiated August 13, 2013

    Recall

    Recall Number
    Z-2214-2013
    Event Number
    66098
    Firm
    Ebi, Llc
    FEI Number
    2242816
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 13, 2013
    Posted
    September 17, 2013
    Terminated
    March 11, 2015
    Address
    100 Interpace Pkwy, Parsippany, NJ, 07054-1149

    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.

    Action

    Biomet Spine & Bone Healing Technologies sent "Urgent Medical Device Recall Notice" letters with Fax-Back Response Forms dated 8/13/2013 to distributors and OR managers via Fed Ex. Follow-up e-mails with a copy of the Recall Notice were sent to distributors on 8/13/2013. Customers with questions may contact 973-299-9300 x2162 Monday to Friday from 8:00 am to 5:00 pm EST.

    Distribution

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

    Quantity

    427 units