BEUDAMED
    FDA Enforcement Class II Terminated

    CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

    Recall: Z-1018-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-1018-2018
    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

    CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

    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

    Item Number: 00-8114-002-10 Lot Numbers: 61744467 61762055 61783714 62249024 62249025 62250377 62250378 62257221 62257223 62261916 62261917

    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