BEUDAMED
    FDA Enforcement Class II Terminated

    Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.

    Recall: Z-1943-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1943-2014
    Event ID
    68482
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Blue Belt Technologies MN
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    June 4, 2014
    Classification Date
    June 27, 2014
    Termination Date
    August 4, 2014
    Address
    2905 Northwest Blvd Ste 40, Plymouth, MN, 55441-2673, United States

    Description

    Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.

    Reason

    Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.

    Code Info

    Lot C785241, Exp 4-2015

    Distribution

    US Nationwide Distribution in the states of CA, PA, and TX

    Quantity

    2