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NuVasive Specialized Orthopedics Recalls
11 recalls on record · October 14, 2020 to November 27, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 27, 2024Medical DevicesFDA
NuVasive Specialized Orthopedics, Inc. recalls Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE
Hazard: Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
December 21, 2022Medical DevicesFDA
NuVasive Specialized Orthopedics, Inc. recalls NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of s
Hazard: During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.
February 2, 2022Medical DevicesFDA
NuVasive Specialized Orthopedics, Inc. recalls MAGEC 1 System
Hazard: Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
December 8, 2021Medical DevicesFDA
NuVasive Specialized Orthopedics, Inc. recalls NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Descriptio
Hazard: The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.
April 14, 2021Medical DevicesFDA
Nuvasive Specialized Orthopedics Inc recalls NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿
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.
April 14, 2021Medical DevicesFDA
Nuvasive Specialized Orthopedics Inc recalls NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic traum
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.
April 14, 2021Medical DevicesFDA
Nuvasive Specialized Orthopedics Inc recalls NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Le
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.
April 7, 2021Medical DevicesFDA
Nuvasive Specialized Orthopedics Inc recalls PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-
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.
April 7, 2021Medical DevicesFDA
Nuvasive Specialized Orthopedics Inc recalls Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthro
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.
April 7, 2021Medical DevicesFDA
Nuvasive Specialized Orthopedics Inc recalls PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal
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.
October 14, 2020Medical DevicesFDA
Nuvasive Specialized Orthopedics Inc recalls NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of
Hazard: During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.