BEUDAMED
    FDA Recall Terminated

    ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

    Recall: Z-1703-2018 · Initiated April 16, 2018

    Recall

    Recall Number
    Z-1703-2018
    Event Number
    79818
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 16, 2018
    Posted
    April 30, 2018
    Terminated
    April 2, 2019
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

    Reason

    There may be burrs on the extraction hole threads.

    Action

    Notification letters distributed on 4/17/18 instructed customers to perform the following: Steps to Take Please take the following actions: " Immediately return unused affected units: Note: On March 19, 2018, one unit was removed from consignment. Two units were implanted prior to the medical device recall. No additional units are in the market. " Reconciliation Form: Complete the reconciliation form and return to your sales consultant or fax to 574-371-4939 or email to [email protected] within five (5) days of this notice. " Records: Retain a copy of the completed reconciliation form in your files along with this notice. " Additional Notifications: o Notify surgeons at your facility by providing them with a copy of this notice. Forward this notice to others in your facility that need to be informed. Clinical Implications and Patient Impact DePuy (Ireland) is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients that received the affected units.

    Distribution

    The products were distributed to the following US states: FL, MO, and PA.

    Quantity

    2 units