BEUDAMED
    FDA Enforcement Class II Terminated

    PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

    Recall: Z-1052-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-1052-2018
    Event ID
    78706
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    November 29, 2017
    Classification Date
    March 14, 2018
    Termination Date
    April 2, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

    Reason

    The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

    Code Info

    00-5926-011-01 Knee PFJ FEM, CEMENTED, SZ 1, LEFT 00-5926-012-01 Knee PFJ FEM, CEMENTED, SZ 2, LEFT 00-5926-013-01 Knee PFJ FEM, CEMENTED, SZ 3, LEFT 00-5926-013-02 Knee PFJ FEM, CEMENTED, SZ 3, RIGHT 00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT 00-5926-015-02 Knee PFJ FEM, CEMENTED, SZ 5, RIGHT

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

    Quantity

    13,227 in total