BEUDAMED
    FDA Recall Terminated

    Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

    Recall: Z-0021-2015 · Initiated September 17, 2014

    Recall

    Recall Number
    Z-0021-2015
    Event Number
    69280
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 17, 2014
    Posted
    October 6, 2014
    Terminated
    July 14, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46581

    Description

    Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

    Reason

    Investigation determined that units supplied were missing the 4x21 degree helix angle.

    Action

    On September 17, 2014, "URGENT MEDICAL DEVICE RECALL NOTICE" was sent to the consignee Biomet Global Supply Chain Center (GSCC) by email and FedEx. GSCC notified all of the customers within Europe, the Middle East, and Asia that received the affected product. The recall notification included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call (574) 372-1570.

    Distribution

    International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.

    Quantity

    4