BEUDAMED
    FDA Enforcement Class II Terminated

    Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures

    Recall: Z-2876-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2876-2018
    Event ID
    80548
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 29, 2018
    Initiation Date
    June 22, 2018
    Classification Date
    August 18, 2018
    Termination Date
    October 9, 2019
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures

    Reason

    The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower.

    Code Info

    63465803, 63762260, 63767434, 63799794

    Distribution

    Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands.

    Quantity

    385