Drug recall
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate…
FDA recall event 98214 · Class II · Tyber Medical
Key facts
| Event ID | 98214 |
|---|---|
| Recall numbers | Z-1131-2026, Z-1132-2026 |
| Recalling firm | Tyber Medical |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The supplier manufactured anatomical left plates with an incorrect thread orientation. |
| Initiation date | Dec 19, 2025 |
| Report date | Jan 28, 2026 |
| City | Bethlehem |
| State | PA |
| Country | United States |
| FEI number | 3012966183 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: