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NuVasive Specialized Orthopedics, Inc. FDA Recalls
9 recalls on file across devices, 0 of them Class I and 9 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICEClass IISep 30, 2024Due to potential issues with design, manufacturing and docum |
| NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of sClass IINov 1, 2022During accelerated shelf-life extension studies it was noted |
| NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product DescriptioClass IIOct 29, 2021The Instructions for Use have been updated to include: (1) |
| NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ Class IIFeb 12, 2021Due to not having the full complement of biological assessme |
| Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthroClass IIFeb 12, 2021Due to complaints of adverse events potentially related to b |
| NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb LeClass IIFeb 12, 2021Due to not having the full complement of biological assessme |
| PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-Class IIFeb 12, 2021Due to complaints of adverse events potentially related to b |
| NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic traumClass IIFeb 12, 2021Due to not having the full complement of biological assessme |
| PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malClass IIFeb 12, 2021Due to complaints of adverse events potentially related to b |