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.
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 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 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.
Patients and healthcare providers should stop using the device immediately. For instructions, contact Tyber Medical or consult your healthcare provider.
For further information, email Tyber Medical. Additional details are available on the FDA's recall page.
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