BEUDAMED
    FDA Enforcement Class II Terminated

    CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability

    Recall: Z-1048-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-1048-2018
    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

    CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability

    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

    00-5952-016-01 61774124 00-5952-016-01 61782595 00-5952-016-06 11004288 00-5952-017-01 11005095

    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