FDA recall, , Moderate risk
Tyber Medical VOLT Wrist Treatment System Distal Radius Plates
The VOLT Wrist Treatment System plates have incorrect thread orientation, which can cause a problem.
Summary by Recall Canary from the FDA notice
What happened
Tyber Medical of Bethlehem, Pennsylvania recalled the VOLT Wrist Treatment System 2.4/2.7 2 Column Distal Radius Plates because the supplier manufactured anatomical left plates with an incorrect thread orientation. The recall began December 19, 2025, and the FDA added it to its Enforcement Report on January 20, 2026. The plates were distributed in Pennsylvania.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI, lot code and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
VOLT" Wrist Treatment System 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm
- UDI-DI
- 00196449020508
- Model/Catalog number
- 02.426.681S
- Lot code
- 291294
VOLT" Wrist Treatment System 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm
- UDI-DI
- 00196449020522
- Model/Catalog number
- 02.426.691S
- Lot code
- 291293
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Pennsylvania.
- Company
- Tyber MedicalBethlehem, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98214
- Recall numbers
- Z-1131-2026 to Z-1132-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
