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FDA Devices Verify with FDA Devices → Moderate Class II Ongoing

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 lengt

Reported: April 14, 2021 Initiated: February 12, 2021 #Z-1350-2021 229 units units

Nuvasive Specialized Orthopedics Inc issued this FDA Devices recall on April 14, 2021. Classified as Moderate severity (Class II). Approximately 229 units units are affected. The recall was issued because: Due to not having the full complement of biological assessments for all potential patients and as a result the devices …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-1350-2021) was formally reported on April 14, 2021, with the manufacturer initiating the action on February 12, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Nuvasive Specialized Orthopedics Inc is listed as the recalling firm, operating out of Aliso Viejo, CA. Federal records indicate 229 units units are affected.

The documented reason for this recall is: 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 data in the federal record shows the product reached: Worldwide distribution, including U.S. Nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

229 units

Related Recalls

6

6 from same agency

Product Description

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 PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; PRECICE Trauma Nail System/Precice Unyte-Tibia Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 300 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 315 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 330 mm length; Orthopedic trauma intra

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.

Details

Units Affected
229 units
Distribution
Worldwide distribution, including U.S. Nationwide.
Location
Aliso Viejo, CA

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-1350-2021
Date reported April 14, 2021
Date initiated February 12, 2021
Recalling firm Nuvasive Specialized Orthopedics Inc
Units affected 229 units
Distribution Worldwide distribution, including U.S. Nationwide.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

229 units units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) —
Large-scale (100K – 1M units) —
Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼
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 PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; PRECICE Trauma Nail System/Precice Unyte-Tibia Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 300 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 315 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 330 mm length; Orthopedic trauma intra. Recalled by Nuvasive Specialized Orthopedics Inc. Units affected: 229 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1350-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution, including U.S. Nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1350-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).