The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1350-2021·Announced 2021-04-14

Nuvasive Precice Unyte Orthopedic Rods Recalled for Missing Biological Assessments

Nuvasive Specialized Orthopedics is recalling Precice Unyte orthopedic trauma nails because they lack full biological assessments and are not indicated for patients under 18.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a lack of biological assessment data for a specific age group (under 18), which is a regulatory and safety precaution rather than a reported injury or death.

Plain-English summary

Nuvasive Specialized Orthopedics Inc is recalling the NUVASIVE PRECICE UNYTE System (Humerus and Tibia), which includes orthopedic trauma intramedullary rods, end caps, and locking screws. The recall affects 229 units distributed worldwide, including the United States. The affected lots were manufactured between April 2015 and February 2021.

The recall is being conducted because the devices do not have the full complement of biological assessments for all potential patients. As a result, the devices are not indicated for use in individuals under the age of 18 years old.

Healthcare providers and patients should check their inventory and patient records for the specific product codes and GTIN numbers listed in the official recall notice. If the devices are found, they should be removed from use and returned to the manufacturer or disposed of according to the recall instructions.

The recalled product

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…
Manufacturer
Nuvasive Specialized Orthopedics Inc
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
229

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • humerus
  • 8.5 mm diameter: CDH8.5-20L165
  • CDH8.5-20L180
  • CDH8.5-30L195
  • CDH8.5-50L210
  • CDH8.5-50M225
  • CDH8.5-50M240
  • CDH8.5-80M255
  • CDH8.5-80M270
  • CDH8.5-80M285
  • CDH8.5-80M300
  • end cap for trauma intramedullary humeral nail: HEC1-000
  • HEC2-000
  • HEC3-000
  • HEC4-000
  • HEC5-000
  • Locking screws: LSB3-020
  • LSB3-025
  • LSB3-030
  • LSB3-035

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Nuvasive Specialized Orthopedics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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