FDA-Device2021-04-14Class II
NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 210 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 225 mm lengt
Nuvasive Specialized Orthopedics Inc
Hazard
Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
Sold states
Worldwide distribution, including U.S. Nationwide.
Affected count
229 units
Manufactured in
101 Enterprise Ste 100, N/A, Aliso Viejo, CA, United States
Products
NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 210 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 225 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 300 mm length; End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; PRECICE Trauma Nail System/Precice Unyte-Tibia Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 300 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 315 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 330 mm length; Orthopedic trauma intra
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1350-2021Don't want to check this manually?
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