BEUDAMED
    FDA Enforcement Class II Terminated

    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.

    Recall: Z-0495-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0495-2015
    Event ID
    69630
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer CAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    November 3, 2014
    Classification Date
    December 2, 2014
    Termination Date
    February 13, 2015
    Address
    75 Queen St #3300, N/A, Montreal, N/A, N/A, Canada

    Description

    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.

    Reason

    Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw.

    Code Info

    BKL0398L 20-8070-002-01; DHA0645L 20-8070-002-01; DHA0646R 20-8070-002-02; ECO0516L 20-8070-002-01; GHE0651R 20-8070-002-02; KAD0595L 20-8070-002-01; KWI0523R 20-8070-002-02; MHA0483L 20-8070-002-01; MHA0484R 20-8070-002-02; MKE0659R 20-8070-002-02; MMA0728R 20-8070-002-02; SSC0782L 20-8070-001-01; TCA0582L 20-8070-002-01; THO0803L 20-8070-002-01; TMA0760L 20-8070-002-01; Expiration dates 5/8/14-12/31/15

    Distribution

    US Distribution in states of: AZ, CO, IL, OR, and WA.

    Quantity

    15