BEUDAMED
    FDA Recall Terminated

    Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, INSTRUMENTS 414926 & 414923 MAY BE REQUIRED LOT 183300, 1 SET, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE, P.O. BOX 587 WARSAW, IN 46581 USA EXPIRY DATE: 2021-03 Elbow joint replacement prosthesis intended for primary and revision joint arthroplasty for use in cemented applications.

    Recall: Z-2660-2011 · Initiated April 29, 2011

    Recall

    Recall Number
    Z-2660-2011
    Event Number
    58864
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDC
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 29, 2011
    Posted
    June 24, 2011
    Terminated
    August 29, 2011
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, INSTRUMENTS 414926 & 414923 MAY BE REQUIRED LOT 183300, 1 SET, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE, P.O. BOX 587 WARSAW, IN 46581 USA EXPIRY DATE: 2021-03 Elbow joint replacement prosthesis intended for primary and revision joint arthroplasty for use in cemented applications.

    Reason

    The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle.

    Action

    Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated May 25, 2011 to all affected customers. The notice describes the product, problem, and actions to be taken by the customers. The notice instructed customers to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Additionally, customers were instructed to ship the package priority mail with a copy of the response form. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday 8 AM to 5 PM.

    Distribution

    Worldwide Distribution--USA (nationwide) including the states of AR and SD and the country of Japan.

    Quantity

    10 KITS