BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992

    Recall: Z-3252-2018 · Reported October 3, 2018

    Enforcement

    Recall Number
    Z-3252-2018
    Event ID
    80918
    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
    October 3, 2018
    Initiation Date
    August 3, 2018
    Classification Date
    September 26, 2018
    Termination Date
    April 10, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992

    Reason

    Expiration date incorrectly listed on the label

    Code Info

    Lot Numbers: 053940, 545740, 067490, 664610, 165770, 676180, 165830, 688250, 415590, 860050

    Distribution

    AZ CO FL FL GA LA MA MA MO NY SC TX

    Quantity

    217 units