BEUDAMED
    FDA Recall Terminated

    Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 4, 25.0 mm; Ref 96-0546.

    Recall: Z-1226-05 · Initiated May 26, 2005

    Recall

    Recall Number
    Z-1226-05
    Event Number
    32192
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    NJL
    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. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 4, 25.0 mm; Ref 96-0546.

    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

    36