Nuvasive Specialized Orthopedics Inc 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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 complaints@nuvasive.com. 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.