NuVasive recalls Freedom end caps for PRECICE limb lengthening systems due to lack of biological assessments for patients under 18. Affected items were sold from April 2015 to February 2021.
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 end caps and screws for their PRECICE limb lengthening system because the devices weren't properly tested for use in children under 18. This means these products shouldn't be used on anyone under 18 years old.
The devices were not fully tested for all potential patients, so they are not approved for use in individuals under 18 years old. This means using them on children could lead to improper medical outcomes.
Patients using the PRECICE limb lengthening system with these end caps or screws are affected. Children under 18 years old are at risk if the device is used on them without proper medical approval.
Check for NuVasive Freedom end caps with product codes CPA1-000 through CPA3-020 or locking screws with codes LSB4-020 through LSC5-100. These items were sold between April 2015 and February 2021.
Look for specific product codes listed in the recall notice to confirm if your item is affected.
Ensure the device is not being used on individuals under 18 years old, as it is not approved for this age group.
The devices were not fully tested for all potential patients, so they are not approved for use in individuals under 18 years old.
Affected end caps have codes CPA1-000 through CPA3-020, and locking screws have codes LSB4-020 through LSC5-100.
These products were sold between April 2015 and February 2021.
We’ve drafted a message you can send NuVasive to request your refund or repair — edit it as you like.
Subject: Recall Z-1351-2021 — NuVasive NuVasive Hello, I own a NuVasive that is covered by recall Z-1351-2021 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.
