FDAFebruary 12, 2021device
NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm; Packaged End Cap 12.5mm,¿ +0...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
nuvasive specialized orthopedicsnuvasivenuvasive specialized
UPCs
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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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