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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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.

The Hazard

The anatomical left plates were manufactured with an incorrect thread orientation. This defect can lead to improper fit and function, posing a risk to patient safety.

Reported Incidents

There are no reported injuries or incidents associated with this recall. However, the potential for harm remains high due to the critical nature of the product's application.

What to Do

Patients and healthcare providers should stop using the device immediately. For instructions, contact Tyber Medical or consult your healthcare provider.

Contact Information

For further information, email Tyber Medical. Additional details are available on the FDA's recall page.

Key Facts

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

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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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