BEUDAMED
    FDA Recall Terminated

    PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.

    Recall: Z-1712-2014 · Initiated April 30, 2014

    Recall

    Recall Number
    Z-1712-2014
    Event Number
    68326
    Firm
    Microport Orthopedics INC.
    FEI Number
    3010536692
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 30, 2014
    Posted
    June 4, 2014
    Terminated
    December 1, 2014
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    Description

    PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.

    Reason

    Difficulty removing the cup adaptor from the impaction handle during surgery

    Action

    Firm has initiated the recall by email on 04/28/2014 to all distributor's offices, including international, then followed with written communication on 05/02/2014 via Fed Ex P1 delivery to all United States consignees. Follow-up to non-responding consignees will commence 30 days after initiation.

    Distribution

    Nationwide Distribution.

    Quantity

    140 units