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.
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.