Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14S...

FDA Recall #Z-1132-2026 — Class II — December 19, 2025

Recall #Z-1132-2026 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/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

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

64 units

Distribution

US Nationwide distribution in the state of PA.

Code Information

Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated