FDA-Device2020-10-14Class II
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).
Nuvasive Specialized Orthopedics Inc
Hazard
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
Sold states
Worldwide distribution. US nationwide, Austria, Australia, Canada, Switzerland, Denmark, Spain, France, United Kingdom, Germany, UAE, Luxembourg, Israel, Netherlands.
Affected count
41 total units
Manufactured in
101 Enterprise Ste 100, N/A, Aliso Viejo, CA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2021Don't want to check this manually?
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