BEUDAMED
    FDA Enforcement Class II Terminated

    Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture

    Recall: Z-1793-2012 · Reported June 20, 2012

    Enforcement

    Recall Number
    Z-1793-2012
    Event ID
    61332
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2012
    Initiation Date
    February 21, 2012
    Classification Date
    June 9, 2012
    Termination Date
    January 15, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture

    Reason

    During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem.

    Code Info

    NR068K, TIBIA PLATEAU, FIXED, T0; NR070K, TIBIA PLATEAU, FIXED, T0+; NR072K, TIBIA PLATEAU, FIXED, T1; NR072K, TIBIA PLATEAU, FIXED, T1+; NR073K, TIBIA PLATEAU, FIXED, T2; NR074K, TIBIA PLATEAU, FIXED, T2+; NR075K, TIBIA PLATEAU, FIXED, T3; NR076K, TIBIA PLATEAU, FIXED, T3+; NR077K, TIBIA PLATEAU, FIXED, T4; NR078K, TIBIA PLATEAU, FIXED, T4+; NR079K, TIBIA PLATEAU, FIXED, T5

    Distribution

    Nationwide Distribution including PA and TX.

    Quantity

    8