# FDA recall Z-0500-2025

> **NuVasive Specialized Orthopedics, Inc.** · Class II · device recall initiated 2024-09-30.

## Product

Precice Max REF:  PM10.0-80B265	PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm  	  PM10.0-80B280	PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm  		  PM10.0-80B305	PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm  	  PM10.0-80B335	PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm  	  PM10.0-80B365	PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm  	  PM10.0-80TJ265	PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 265mm  	  PM10.0-80TJ280	PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 280mm  	  PM10.0-80TJ305	PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 305mm    PM11.5-80B265	PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm  	  PM11.5-80B280	PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm  	  PM11.5-80B305	PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm  	  PM11.5-80B335	PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm  	  PM11.5-80B365	PRECI

## Reason for recall

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

## Distribution

U.S distribution to states of: FL and NV.

## Key facts

- **Recall number:** Z-0500-2025
- **Recalling firm:** NuVasive Specialized Orthopedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-30
- **Report date:** 2024-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aliso Viejo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0500-2025

## Citation

> AI Analytics. FDA recall Z-0500-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0500-2025. Source: US FDA. Licensed CC0.

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