BEUDAMED
    FDA Enforcement Class II Terminated

    EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    Recall: Z-2636-2020 · Reported July 22, 2020

    Enforcement

    Recall Number
    Z-2636-2020
    Event ID
    85517
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Skeletal Kinetics, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 22, 2020
    Initiation Date
    April 6, 2020
    Classification Date
    July 15, 2020
    Termination Date
    February 24, 2021
    Address
    3885 Arapaho Rd, N/A, Addison, TX, 75001-4314, United States

    Description

    EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    Reason

    Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

    Code Info

    Lot Number: 17081106, 17120617.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, WI and the countries of Australia, Canada, South Africa, Switzerland.

    Quantity

    60