BEUDAMED
    FDA Recall 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 · Initiated November 17, 2016

    Recall

    Recall Number
    Z-0943-2017
    Event Number
    75888
    Firm
    MicroPort Orthopedics Inc.
    FEI Number
    3010536692
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 17, 2016
    Posted
    January 3, 2017
    Terminated
    August 18, 2018
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    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.

    Action

    MicroPort Orthopedics sent an Voluntary Device Product Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed form even if they do not have any affected product to return. Return the completed form by fax to 1-901-451-6032 or by email to [email protected]. Attempt #1 for acknowledgment will be made by email. For questions regarding this recall call 901-867-4318.

    Distribution

    Worldwide Distribution to Spain, China, and Italy

    Quantity

    20 units