BEUDAMED
    FDA Recall Terminated

    Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.

    Recall: Z-1942-2014 · Initiated June 4, 2014

    Recall

    Recall Number
    Z-1942-2014
    Event Number
    68482
    Firm
    Blue Belt Technologies MN
    FEI Number
    3010266064
    Product Code
    HSX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 4, 2014
    Posted
    June 27, 2014
    Terminated
    August 4, 2014
    Address
    2905 Northwest Blvd, Ste 40, Plymouth, MN, 55441-2673

    Description

    Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. 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.

    Action

    Firm initiated recall on 6/4/2014 by Blue Belt Technologies representatives hand delivering an Urgent Medeical Device Recall letter. The letter was addressed to the attention of Safety Officer/Regulatory Compliance Officer. The letter described the issue of the labeling mix-up, asked for devices to be quarantined, and stated that a Blue Belt Technologies Clinical Specialist will be contacting the consignee or return and replacement. A Receipt Acknowledgement form was asked to be returned by fax or mail.

    Distribution

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

    Quantity

    2