BEUDAMED
    FDA Recall Terminated

    Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic Xomed, Inc., Jacksonville, Florida 32216 U.S.A.

    Recall: Z-0536-2010 · Initiated July 27, 2009

    Recall

    Recall Number
    Z-0536-2010
    Event Number
    52837
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    LRK
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 27, 2009
    Posted
    December 15, 2009
    Terminated
    March 15, 2010
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic Xomed, Inc., Jacksonville, Florida 32216 U.S.A.

    Reason

    Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.

    Action

    Firm notified customers by phone on 7/27/2009. Firm asked customers to check inventories for the affected products listed on the enclosed Checklist. 1. Fill-in the "quantity on-hand "column on the checklist. 2. If you have any this product lot, contact Medtronic ENT Customer Service at 800-874-5797 (select Option 1 for Customer Service) and ask for the REPOSE Field Action Contact Person for help to arrange for returns and replacements or credit. 3. Fax your Checklist to Medtronic ENT at the number provided. 4. Return products clearly marked.

    Distribution

    9 consignees in the continental United States.

    Quantity

    13