BEUDAMED
    FDA Enforcement Class II Terminated

    PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This

    Recall: Z-0943-2017 · Reported January 11, 2017

    Enforcement

    Recall Number
    Z-0943-2017
    Event ID
    75888
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroPort Orthopedics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 11, 2017
    Initiation Date
    November 17, 2016
    Classification Date
    January 3, 2017
    Termination Date
    August 18, 2018
    Address
    5677 Airline Rd, N/A, Arlington, TN, 38002-9501, United States

    Description

    PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This

    Reason

    The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an associated broach.

    Code Info

    Lot Number US100122

    Distribution

    Worldwide Distribution to Spain, China, and Italy

    Quantity

    20 units