BEUDAMED
    FDA Enforcement Class II Terminated

    Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

    Recall: Z-1366-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1366-2013
    Event ID
    61315
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    March 7, 2012
    Classification Date
    May 22, 2013
    Termination Date
    May 24, 2013
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

    Reason

    DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a 36IDX56OD Neutral Liner. Three ( 3 ) complaints were received in January 2012.

    Code Info

    product code1221-36-452, lot 187460.

    Distribution

    Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.

    Quantity

    20 liners