FDA DevicesClass II
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Rad...
Published: January 28, 2026Recall ID: Z-1132-2026Category: devicesCountry: US
Reason for Recall / Hazard
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Product Description & Identification
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
Affected Products
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
Additional Source Details
| Field | Value |
|---|---|
| City | Bethlehem |
| State | PA |
| Event id | 98214 |
| Address 1 | 83 S Commerce Way Ste 310 |
| Code info | Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293 |
| Postal code | 18017-8934 |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 64 units |
| Reason for recall | The supplier manufactured anatomical left plates with an incorrect thread orientation. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | |
| Center classification date | 20260120 |
Overview
- Recalling FirmTyber Medical
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of PA.