BEUDAMED
    FDA Recall Terminated

    Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.

    Recall: Z-0823-2015 · Initiated December 2, 2014

    Recall

    Recall Number
    Z-0823-2015
    Event Number
    69932
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    December 2, 2014
    Posted
    December 17, 2014
    Terminated
    October 27, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.

    Reason

    After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 348 Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.

    Action

    Sent notices to customers dated 12/2/2014 notifying them of the recall: 5 were implanted, 3 were shipped to subsidiary for testing, and 2 are in Biomet control. Public Contact for the recall is: Audrey Daenzer, Field Action Specialist, Regulatory Compliance [email protected], can be contacted from Monday through Friday 8 AM to 5 PM, 574-372-1570.

    Distribution

    Foreign Distribution in China and Australia only.

    Quantity

    8