Tyber Medical recalled 100 units of its VOLT Wrist Treatment System on December 19, 2025. The recall stems from a manufacturing defect that affects the thread orientation of anatomical left plates. Healthcare providers and patients should stop using the device immediately.
The supplier manufactured anatomical left plates with an incorrect thread orientation.
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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The recalled product is identified as the VOLT Wrist Treatment System, model number 02.426.681S. The system consists of a 2 Column Distal Radius Plate with 6 heads and a 10 shaft, designed specifically for the left wrist. The recall involves 100 units distributed nationwide in the U.S., particularly in Pennsylvania.
The recall was initiated due to the incorrect thread orientation on the anatomical left plates. This defect poses a risk of improper installation, which can lead to complications during treatment.
No injuries or incidents have been reported related to this recall. However, due to the high hazard level, immediate action is advised to prevent potential harm.
Patients and healthcare providers should stop using the recalled device immediately. To obtain instructions, contact Tyber Medical or consult your healthcare provider.
For further information, please contact Tyber Medical via email. Additional details can be found at the FDA recall link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1131-2026.
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