HIGH

Tyber Medical Recalls VOLT Wrist Treatment System Over Thread Issue

Tyber Medical recalled 64 units of the VOLT Wrist Treatment System on December 19, 2025. The recall affects model number 02.426.691S due to incorrect thread orientation in anatomical left plates. Patients and healthcare providers should stop using this device immediately.

Quick Facts at a Glance

Recall Date
December 19, 2025
Hazard Level
HIGH
Brand
Tyber Medical
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

The supplier manufactured anatomical left plates with an incorrect thread orientation.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tyber Medical or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

The VOLT Wrist Treatment System is a medical device used in surgical procedures for treating wrist fractures. Surgeons and healthcare professionals purchase this product for its precision in stabilizing wrist structures during healing.

Why This Is Dangerous

The incorrect thread orientation in the anatomical left plates can lead to improper installation, which may jeopardize the success of surgical procedures and patient recovery.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients relying on this device face potential surgical complications, underscoring the urgent need for immediate action to ensure safety.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number 02.426.691S on your device.
  2. Check for the lot number 291293 for confirmation of the recall.
  3. Contact your healthcare provider if unsure about your device.

Where to find product info

Serial numbers and model information can typically be found on the product packaging or the device itself, often on a label attached to the plate.

What timeline to expect

Expect a response from Tyber Medical regarding refunds or replacements within 4-6 weeks.

If the manufacturer is unresponsive

  • Document all communication attempts with Tyber Medical.
  • Reach out again via email or phone if you do not receive a timely response.
  • Consider filing a complaint with the FDA if necessary.

How to prevent similar issues

  • Always verify product recalls through official channels before use.
  • Check for FDA approval and quality certifications when purchasing medical devices.
  • Consult healthcare professionals about product safety before surgical procedures.

Documentation advice

Keep records of your purchase, including receipts and any correspondence regarding the recall for your records.

Product Details

The recalled product is the VOLT Wrist Treatment System, model number 02.426.691S. It features a 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm. This product was distributed nationwide in the United States, specifically in Pennsylvania.

Key Facts

  • 64 units recalled
  • Model No: 02.426.691S
  • Distributed in Pennsylvania
  • Incorrect thread orientation
  • Class II recall, high hazard level

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model No: 02.426.691S
UDI-DI: 00196449020522
Lot Number: 291293
Affected States
ALL
Report Date
January 28, 2026
Recall Status
ACTIVE

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