BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5; 00-7713-007-00

    Recall: Z-2374-2018 · Reported July 11, 2018

    Enforcement

    Recall Number
    Z-2374-2018
    Event ID
    80188
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 11, 2018
    Initiation Date
    May 30, 2018
    Classification Date
    July 5, 2018
    Termination Date
    May 28, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5; 00-7713-007-00

    Reason

    M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

    Code Info

    62420821 62745221 62848683 63089985 63161324 62647157R

    Distribution

    Products were distributed solely to Japan.

    Quantity

    58