Unrated Medical device recall · FDA · Published September 30, 2024

NuVasive Precice Max Orthopedic Devices Recall: Design and Documentation Issues

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0500-2025Medical device NuVasive ›

Recall notice

Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.

Take action

Contact the company

Recalling firmNuVasive Specialized Orthopedics, Inc.101 Enterprise Ste 100 · Aliso Viejo, CA 92656-2604

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/53844-nuvasive-precice-max-orthopedic-devices-recall-design-and-documentation-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/53844-nuvasive-precice-max-orthopedic-devices-recall-design-and-documentation-issues · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0500-2025

Cite this page

“NuVasive Precice Max Orthopedic Devices Recall: Design and Documentation Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53844-nuvasive-precice-max-orthopedic-devices-recall-design-and-documentation-issues. Based on FDA recall #Z-0500-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0500-2025%22&limit=1).

NuVasive Specialized Orthopedics, Inc. recalled Precice Max orthopedic devices due to potential design, manufacturing and documentation issues related to validation, the FDA said on Sept. 30, 2024.

How to tell if you have it

Precice Max REF: PM10.0-80B265
Precice Max REF: PM10.0-80B280
Precice Max REF: PM10.0-80B305
Precice Max REF: PM10.0-80B335
Precice Max REF: PM10.0-80B365
Precice Max REF: PM10.0-80TJ265
Precice Max REF: PM10.0-80TJ280
Precice Max REF: PM10.0-80TJ305
Precice Max REF: PM11.5-80B265
Precice Max REF: PM11.5-80B280
Precice Max REF: PM11.5-80B305
Precice Max REF: PM11.5-80B335
Precice Max REF: PM11.5-80B365
Precice Max REF: PM11.5-80TJ265
Precice Max REF: PM11.5-80TJ280
Precice Max REF: PM11.5-80TJ305
Precice Max REF: PM13.0-80B280
Precice Max REF: PM13.0-80B305
Precice Max REF: PM13.0-80B365

The hazard

The recall addresses potential issues with design, manufacturing and documentation related to the validation of the affected products/devices.

Context

NuVasive Specialized Orthopedics, Inc. has 6 other recalls on record since 2019-06-25. Other recent recalls include a NuVasive MAGEC 2 Rod Recall (2022-11-01), a NuVasive Precice IMLL System update (2021-10-29) and a Nuvasive Precice Bone Transport recall (2021-02-12). Other recent recalls of similar products include a Medtronic Octopus Nuvo Tissue Stabilizer Recall (2026-01-13), a Merit Medical Custom Procedure Kit Recall (2025-12-04) and a Howmedica SCORPIO Mobile Bearing PCS Recall (2026-07-30).

How to tell if you have this one

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.

Brand
NuVasive
Product
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model numbers listed in the recall to determine if your device is affected.

Where it went and when

Where it was distributed

Distributed in Florida and Nevada.

FDA distribution: “U.S distribution to states of: FL and NV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Nevada.

Recall timeline

FDA published this recall 58 days after the firm started it.

Sep 30, 2024Firm started the recall
Nov 21, 2024FDA classified it Class II
Nov 27, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53844-nuvasive-precice-max-orthopedic-devices-recall-design-and-documentation-issues">NuVasive Precice Max Orthopedic Devices Recall: Design and Documentation Issues (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0500-2025 (September 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0500-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.