Brand Name: VOLT" Wrist Treatment System Product Name: 2 — Class II medical device recall Z-1131-2026
Ongoing recall by Tyber Medical, reported 2026-01-28, distributed nationwide. The supplier manufactured anatomical left plates with an incorrect thread orientation.
| Recall number | Z-1131-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tyber Medical, Bethlehem, PA, United States |
| Recall initiated | 2025-12-19 |
| Classified | 2026-01-20 |
| Reported by FDA | 2026-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 100 units |
| UPC / GTIN / UDI-DI | 00196449020508 |
| Lot numbers | 291294 |
| Model numbers | 02.426.681S |
Product
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 for recall
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1131-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.