Recall Z-0069-2021 · HSB Rod, Fixation, Intramedullary And Accessories
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).
| Date | Jul 24, 2020 |
| Status | Open, Classified |
| Reason | During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system. |
| Root cause | Device Design |
| 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 conta |
| Quantity | 41 total units |
| Distribution | Worldwide distribution. US nationwide, Austria, Australia, Canada, Switzerland, Denmark, Spain, France, United Kingdom, Germany, UAE, Luxembourg, Israel, Netherlands. |
| FDA record | Open on fda.gov |