NuVasive recalls PRECICE Unyte Humerus and Tibia trauma nail systems due to insufficient biological assessments for patients under 18. These devices are not indicated for use in individuals under 18 years old.
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 its PRECICE Unyte Humerus and Tibia trauma nail systems because they were not properly tested for use in patients under 18 years old. This means these devices should not be used on children or teenagers.
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 or teenagers could lead to complications.
Patients under 18 years old who have received this specific orthopedic trauma device are at risk. The recall affects individuals who have been implanted with the PRECICE Unyte system.
Check for the PRECICE Unyte system with the listed product codes (e.g., CDH8.5-20L165 for humerus rods) or GTIN numbers provided in the recall. All units manufactured between April 2015 and February 2021 are affected.
Look for the specific product codes listed in the recall, such as CDH8.5-20L165 for humerus rods or CDT11.5-30T240 for tibia rods.
Reach out to NuVasive Specialized Orthopedics, Inc. for further guidance on the recall and potential remedies.
No, these devices are not approved for use in individuals under 18 years old due to insufficient biological assessments.
Check the product codes or GTIN numbers listed in the recall to confirm if your device is affected. Contact NuVasive Specialized Orthopedics, Inc. for further instructions.
The recall covers all units manufactured 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-1350-2021 — NuVasive NuVasive Hello, I own a NuVasive that is covered by recall Z-1350-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
