BEUDAMED
    FDA Enforcement Class II Ongoing

    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-12

    Recall: Z-1713-2024 · Reported May 8, 2024

    Enforcement

    Recall Number
    Z-1713-2024
    Event ID
    94276
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 8, 2024
    Initiation Date
    March 20, 2024
    Classification Date
    April 30, 2024
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-12

    Reason

    Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention

    Code Info

    UDI: (01)00889024088535(17)290809(10)64475610 (01)00889024088535(17)310331(10)65038408 (01)00889024088535(17)310324(10)65038409 (01)00889024088535(17)310915(10)65209412 (01)00889024088535(17)310915(10)65209413 Lot Numbers: 64475610 65038408 65038409 65209412 65209413

    Distribution

    Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.