BEUDAMED
    FDA Recall 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 · Initiated May 15, 2014

    Recall

    Recall Number
    Z-1925-2014
    Event Number
    68418
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 15, 2014
    Posted
    June 26, 2014
    Terminated
    March 16, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    Biomet sent an Urgent Medical Device Recall Notice letter dated May 28, 2014 to their customer. The letter identified the affected product, problem and actions to be taken. The letter instructed physician to monitor the patient for any pain that may require surgical intervention. For questions call (574) 372-1570.

    Distribution

    US Nationwide Distribution in the state of California

    Quantity

    1