BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1811-2014 · Initiated May 15, 2014

    Recall

    Recall Number
    Z-1811-2014
    Event Number
    68526
    Firm
    Ebi, Llc
    FEI Number
    2242816
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 15, 2014
    Posted
    June 17, 2014
    Terminated
    April 21, 2017
    Address
    399 Jefferson Rd, Parsippany, NJ, 07054-3707

    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.

    Action

    Biomet sent an "Urgent Medical Device Recall Notice"/Fax Back Response Form dated May 15, 2014, via Fed Ex to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and if located to remove the product from circulation; follow instructions on the attached Fax Back Response Form prior to return of the product; and return the product using the Fed Ex label included with the notification. Customers were instructed, if if they further distributed the product, they must notify their customers of the recall via the enclosed "Dear O.R. Manger" notice. If the customers had any questions they were asked to please contact Biomet, Monday through Friday (8 am to 5 pm) at 973.299.9300 xt. 2322.

    Distribution

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

    Quantity

    32 units (30 domestic and 2 international)