FDAFebruary 12, 2021device
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
What to do
FDA enforcement status: Ongoing
Brands named
nuvasive specialized orthopedicsnuvasivenuvasive specialized
UPCs
008875170219150088751702190800887517021892008875170218850088751702187800887517021861008875170218540088751702184700887517021830008875170218230088751702181600887517021809
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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