BEUDAMED
    FDA Recall 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 · Initiated August 3, 2018

    Recall

    Recall Number
    Z-3252-2018
    Event Number
    80918
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 3, 2018
    Terminated
    April 10, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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

    Action

    Zimmer notified distributors on 8/3/18 distributors notified via email. Hospital risk managers, as well as distributors with product, notified via Fed'X. The letter identifies the issue and their responsibilities, locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. Product to be returned to Zimmer Biomet. Question customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday or to :[email protected]

    Distribution

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

    Quantity

    217 units