Nuvasive Freedom End Caps Recalled for Missing Biological Assessments
Nuvasive Specialized Orthopedics Inc. is recalling 59 units of Freedom End Caps and related components because they lack full biological assessments and are not indicated for patients under 18.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a labeling/indication issue regarding biological assessments and age restrictions, with no reported injuries or illnesses in the source text.
Plain-English summary
Nuvasive Specialized Orthopedics Inc. is recalling 59 units of NUVASIVE Freedom End Caps, locking screws, intramedullary limb lengthening rods, and surgical instruments. The recall covers all lots manufactured between April 2015 and February 2021. The products were distributed worldwide, including nationwide in the United States.
The recall is being conducted because the devices do not have the full complement of biological assessments for all potential patients. As a result, the devices are not indicated for use in individuals under the age of 18 years old.
Healthcare providers and patients should contact Nuvasive Specialized Orthopedics Inc. for instructions on how to return or replace the affected devices. The recall number is Z-1351-2021.
The recalled product
- Product
- 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; Pa
- Manufacturer
- Nuvasive Specialized Orthopedics Inc
- Affected units
- 59
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- CPA2-000
- CPA2-005
- CPA2-010
- CPA2-015
- CPA2-020
- CPA3-000
- CPA3-005
- CPA3-010
- CPA3-015
- CPA3-020
- Locking screws: LSB4-020
- LSB4-025
- LSB4-030
- LSB4-035
- LSB4-040
- LSB4-045
- LSB4-050
- LSB4-055
- LSB4-060
- LSB5-020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Nuvasive Specialized Orthopedics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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