BEUDAMED
    FDA Recall Terminated

    Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 12.5 mm; Ref 98-4144.

    Recall: Z-1333-05 · Initiated May 26, 2005

    Recall

    Recall Number
    Z-1333-05
    Event Number
    32192
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 26, 2005
    Posted
    August 12, 2005
    Terminated
    December 2, 2005
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 12.5 mm; Ref 98-4144.

    Reason

    An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

    Distribution

    Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.

    Quantity

    10