FDAJuly 24, 2020device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
What to do
FDA enforcement status: Ongoing
Brands named
nuvasive specialized orthopedicsnuvasivenuvasive specialized
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCSpecialized Bicycle Components Recalls Specialized Turbo Como SL Electric Bicycles Due to Risk of Serious Injury or Death from Fall Hazard2026-03-19
- FDABrand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE2025-12-19
- FDAOrthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5....2025-11-17
- FDABrand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassi...2025-09-23
- FDAReef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System2025-08-06
- CPSCSpecialized Bicycle Components Recalls Globe-Branded Haul ST and LT E-Bikes Due to Fall Hazard2025-06-05
- CPSCSpecialized Bicycle Components Recalls Vado and Como IGH E-Bikes with Chain Guards Due to Fall Hazard2025-03-27
- FDAComprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 1136272025-03-03
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