BEUDAMED
    FDA Recall Terminated

    Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.

    Recall: Z-1962-2019 · Initiated June 4, 2019

    Recall

    Recall Number
    Z-1962-2019
    Event Number
    83085
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 4, 2019
    Terminated
    July 21, 2021
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.

    Reason

    The products do not have sufficient data to support the labeled shelf life of 10 years.

    Action

    Urgent Medical Device Recall notification letters dated 6/4/19 were sent to customers.

    Distribution

    Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.

    Quantity

    8478 total