Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius... recall (Tyber Medical)
Medical deviceClass IIOngoing
Summary: Tyber Medical is recalling Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm. Reason: The supplier manufactured anatomical left plates with an incorrect thread orientation.
What is being recalled
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
Why
The supplier manufactured anatomical left plates with an incorrect thread orientation.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of PA.
How to tell if yours is affected
Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1131-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 19, 2025 |
| Reported | January 28, 2026 |
| Company | Tyber Medical |
| Company location | Bethlehem, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 100 units |
More recalls from Tyber Medical · all medical device recalls · recalls from December 2025