BEUDAMED
    FDA Recall Terminated

    Medtronic Bone Void Filler, Small - 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-2390-2020 · Initiated April 24, 2020

    Recall

    Recall Number
    Z-2390-2020
    Event Number
    85611
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 24, 2020
    Terminated
    March 31, 2021
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703

    Description

    Medtronic Bone Void Filler, Small - 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.

    Action

    Medtronic notified customers on about 04/24/2020 via "URGENT: Voluntary Market Removal (Recall)" letter. Customers were informed that Medtronic was notified by Skeletal Kinetics LLC that product that may not maintain its setting characteristics for the labeled shelf-life duration of the product, which may lead to a longer period of time required for the product to set at the time of implantation. Instructions included to not use the product and locate and removed the impacted product from inventory, complete the provided Customer Confirmation Form and return it via email to [email protected], and contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.

    Distribution

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

    Quantity

    36 units