BEUDAMED
    FDA Enforcement Class II Terminated

    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.

    Recall: Z-1077-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1077-2014
    Event ID
    67159
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 5, 2014
    Initiation Date
    December 9, 2013
    Classification Date
    February 24, 2014
    Termination Date
    June 10, 2014
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States

    Description

    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.

    Reason

    Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.

    Code Info

    Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)

    Distribution

    Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.

    Quantity

    2