Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1351-2021·Announced 2021-04-14

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Nuvasive Specialized Orthopedics Inc
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
missing-biological-assessments
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.

See all 3 products in this recall →

Same manufacturer · Nuvasive Specialized Orthopedics Inc

See all →

Moderate
Precice Max Orthopedic Implants Recalled for Design and Manufacturing Validation Issues
FDA (Devices) · 2024-11-27
High
NUVASIVE MAGEC 2 Rod Spinal Bracing System Recalled for Sterile Packaging Failure
FDA (Devices) · 2022-12-21
High
MAGEC 1 System Recalled for Post-Implantation Component Fractures
FDA (Devices) · 2022-02-02
Moderate
NUVASIVE PRECICE Limb Lengthening System: Updated Instructions Clarify Patient Selection
FDA (Devices) · 2021-12-08
Moderate
Nuvasive Precice Unyte Orthopedic Rods Recalled for Missing Biological Assessments
FDA (Devices) · 2021-04-14

Same hazard · mis labeling