BEUDAMED
    FDA Enforcement Class II Terminated

    DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.

    Recall: Z-1925-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1925-2014
    Event ID
    68418
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    May 15, 2014
    Classification Date
    June 26, 2014
    Termination Date
    March 16, 2015
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.

    Reason

    Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.

    Code Info

    Catalog/REF #: 114905, Lot #: M846640

    Distribution

    US Nationwide Distribution in the state of California

    Quantity

    1