BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.

    Recall: Z-2391-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2391-2020
    Event ID
    85611
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2020
    Initiation Date
    April 24, 2020
    Classification Date
    June 16, 2020
    Termination Date
    March 31, 2021
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703, United States

    Description

    Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.

    Reason

    Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

    Code Info

    Product number: C07B; GTIN: 00813845020511; Lot Number: 1127302

    Distribution

    Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.

    Quantity

    6 units