BEUDAMED
    FDA Recall 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 · Initiated March 7, 2012

    Recall

    Recall Number
    Z-1366-2013
    Event Number
    61315
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 7, 2012
    Posted
    May 22, 2013
    Terminated
    May 24, 2013
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    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.

    Action

    DePuy Orthopaedics sent an URGENT INFORMATION- MEDICAL DEVICE RECALL NOTICE dated March 7, 2012 via email to all affected distributors and customers. The letter identified the affected product, problem and actions to be taken. Distributors and customers are instructed to cease further distribution or use or of recalled product and to return them to DePuy. The sales representatives are expected to aid customer in returning of recalled product. Distributors and sales representatives are to return the recalled product through the normal DePuy Returns process. Reconciliation form should be completed and returned to your DePuy Sales Representative or faxed to 574-372-7567. For questions about recall information contact the Manager of Customer Quality 574-372-7333.

    Distribution

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

    Quantity

    20 liners