BEUDAMED
    FDA Recall Open, Classified

    NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).

    Recall: Z-0069-2021 · Initiated July 24, 2020

    Recall

    Recall Number
    Z-0069-2021
    Event Number
    86150
    Firm
    Nuvasive Specialized Orthopedics Inc
    FEI Number
    3006179046
    Product Code
    HSB
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 24, 2020
    Address
    101 Enterprise, Ste 100, Aliso Viejo, CA, 92656-2604

    Description

    NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).

    Reason

    During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.

    Action

    On 7/28/2020, the firm sent a "Field Safety Notice" to US and OUS Surgeons, and Distributors via email informing them of an update removal/explantation process and reminding them to follow the Instructions for Use. Customers are instructed to: -Review, complete, sign (via DocuSign) and return the Consignee Confirmation Form that is accompanying the notification. Directions are located on the form. -Make sure Instruction for Use are followed -Forward the notice to anyone in their facility that needs to be informed. Any questions or assistance that is needed, customers are instructed to contact the Recalling Firm at [email protected]. On 8/6/2020, the firm sent a revised/updated "URGENT FIELD SAFETY NOTICE" to US and OUS Surgeons and Distributors via email informing them of that the internal components of the Bone Transport Nail may remain in the patient, which may lead to a revision surgery. In addition, if adverse reactions or quality problems are experienced with the use of the affected product, customers should report the adverse event to FDA's MedWatch Adverse Event Reporting program online at www.fda.gov, by regular mail to: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20853 or by fax at 800-332-0178.

    Distribution

    Worldwide distribution. US nationwide, Austria, Australia, Canada, Switzerland, Denmark, Spain, France, United Kingdom, Germany, UAE, Luxembourg, Israel, Netherlands.

    Quantity

    41 total units