# FDA recall Z-1350-2021

> **Nuvasive Specialized Orthopedics Inc** · Class II · device recall initiated 2021-02-12.

## Product

NUVASIVE PRECICE UNYTE System (Humerus and Tibia):    PRECICE Trauma Nail System/PRECICE Unyte-Humerus  Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length;  Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length;  Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length;  Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 210 mm length;  Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 225 mm length;  Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 240 mm length;  Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 255 mm length;  Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 270 mm length;  Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 285 mm length;  Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 300 mm length;  End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm);  End Cap for 

## Reason for recall

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.

## Distribution

Worldwide distribution, including U.S. Nationwide.

## Key facts

- **Recall number:** Z-1350-2021
- **Recalling firm:** Nuvasive Specialized Orthopedics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-12
- **Report date:** 2021-04-14

- **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-1350-2021

## Citation

> AI Analytics. FDA recall Z-1350-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1350-2021. Source: US FDA. Licensed CC0.

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