Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10S...

FDA Recall #Z-1131-2026 — Class II — December 19, 2025

Recall #Z-1131-2026 Date: December 19, 2025 Classification: Class II Status: Ongoing

Product Description

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.

Recalling Firm

Tyber Medical — Bethlehem, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

100 units

Distribution

US Nationwide distribution in the state of PA.

Code Information

Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated