NuVasive recalls specific Precice Max orthopedic devices due to potential design and documentation issues affecting validation. Affected models include various sizes for femur and tibia fractures.
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
NuVasive is recalling specific Precice Max orthopedic devices that may have design and documentation issues affecting their validation. These devices are used to stabilize fractures and provide magnetically controlled lengthening of bones. If you own one of the recalled models, you should check the details below.
The recall is due to potential issues with design, manufacturing, and documentation related to the validation of the devices. This could affect their intended use for stabilizing fractures and providing magnetically controlled lengthening of bones.
Patients and medical professionals who use or own the recalled Precice Max devices for bone stabilization and lengthening procedures are most at risk. The recall affects specific model numbers and sizes.
Check if your device has the model numbers listed in the recall: PM10.0-80B265, PM10.0-80B280, PM10.0-80B305, PM10.0-80B335, PM10.0-80B365, PM10.0-80TJ265, PM10.0-80TJ280, PM10.0-80TJ305, PM11.5-80B265, PM11.5-80B280, PM11.5-80B305, PM11.5-80B335, PM11.5-80B365, PM11.5-80TJ265, PM11.5-80TJ280, PM11.5-80TJ305, PM13.0-80B280, PM13.0-80B305, PM13.0-80B365. The devices are used for femur and tibia fractures.
Look for the model numbers listed in the recall to determine if your device is affected.
The recall includes specific Precice Max devices with model numbers such as PM10.0-80B265, PM10.0-80B280, PM10.0-80B305, and others for femur and tibia fractures.
The recall is due to potential issues with design, manufacturing, and documentation related to the validation of the devices.
Check the model numbers listed in the recall to see if your device is affected. If it is, you should contact NuVasive for further instructions.
We’ve drafted a message you can send NuVasive to request your refund or repair — edit it as you like.
Subject: Recall Z-0500-2025 — NuVasive NuVasive Hello, I own a NuVasive that is covered by recall Z-0500-2025 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.
