BEUDAMED
    FDA Recall Terminated

    Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic).

    Recall: Z-3106-2011 · Initiated June 27, 2011

    Recall

    Recall Number
    Z-3106-2011
    Event Number
    59229
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    FEI Number
    1221934
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 27, 2011
    Posted
    August 31, 2011
    Terminated
    January 19, 2012
    Address
    325 Paramount Dr, Raynham, MA, 02767

    Description

    Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic).

    Reason

    Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head.

    Action

    Depuy Mitek issued Original Customer Notification Letter on 6/27/11 and an Updated letter to clarify the lot number information sent 6/29/11. Hospitals requested to immediately check all inventories for affected product and return for repalcement product. Also notify surgeons aware of this potential issue and potential risk of a delay in surgery. questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-800-382-4682, PROMPT 3.

    Distribution

    Nationwide distribution.

    Quantity

    75 units