NuVasive recalls PRECICE limb lengthening system end caps and screws manufactured between April 2015 and February 2021 that are not indicated for use in individuals under 18 years old due to incomplete biological assessments.
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.
NuVasive is recalling specific PRECICE limb lengthening system components (end caps and screws) made between April 2015 and February 2021 because they were not approved for use in patients under 18 years old. This means these devices should not be used on children or adolescents, as they lack the necessary safety testing for younger patients.
The devices were not fully tested for safety in patients under 18 years old. This means they could cause harm if used on children or adolescents, as the biological assessments were incomplete for this age group.
Individuals who own or use these specific PRECICE limb lengthening system components for bone growth procedures. Children and adolescents under 18 years old are at risk of potential complications due to the devices not being approved for their age group.
Check for PRECICE limb lengthening system end caps and screws with product codes listed in the recall (e.g., CPA1-000, CPA2-000, LSB3-020) manufactured between April 2015 and February 2021. Also look for GTIN numbers listed in the recall.
Identify if your device has any of the listed product codes (e.g., CPA1-000, CPA2-000, LSB3-020) manufactured between April 2015 and February 2021.
Reach out to NuVasive Specialized Orthopedics, Inc. for confirmation of your device's eligibility and instructions on next steps.
No, these devices are not approved for use in individuals under 18 years old due to incomplete biological assessments. They should not be used on children or adolescents.
Check for product codes listed in the recall (e.g., CPA1-000, CPA2-000, LSB3-020) manufactured between April 2015 and February 2021, or GTIN numbers provided in the recall.
The recall does not specify a return process, but you should contact NuVasive Specialized Orthopedics, Inc. for guidance on what to do with the recalled devices.
We’ve drafted a message you can send NuVasive to request your refund or repair — edit it as you like.
Subject: Recall Z-1349-2021 — NuVasive NuVasive Hello, I own a NuVasive that is covered by recall Z-1349-2021 from NuVasive. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
