| 2024-09-30 |
Class II
|
Ongoing |
Z-0500-2025 |
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE… |
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Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices. |
| 2022-11-01 |
Class II
|
Ongoing |
Z-0559-2023 |
NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of s… |
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During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier w… |
| 2021-10-29 |
Class II
|
Ongoing |
Z-0319-2022 |
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Descriptio… |
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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 p… |
| 2021-02-12 |
Class II
|
Ongoing |
Z-1351-2021 |
NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ … |
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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 … |
| 2021-02-12 |
Class II
|
Ongoing |
Z-1350-2021 |
NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic traum… |
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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 … |
| 2021-02-12 |
Class II
|
Ongoing |
Z-1349-2021 |
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Le… |
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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 … |
| 2021-02-12 |
Class II
|
Ongoing |
Z-1325-2021 |
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-… |
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Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface be… |
| 2021-02-12 |
Class II
|
Ongoing |
Z-1324-2021 |
Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthro… |
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Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface be… |
| 2021-02-12 |
Class II
|
Ongoing |
Z-1323-2021 |
PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal… |
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Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface be… |
| 2020-07-24 |
Class II
|
Ongoing |
Z-0069-2021 |
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of … |
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During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system. |