FDA recall Z-1132-2026

Tyber Medical · Class II · device

Product

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.

Distribution

US Nationwide distribution in the state of PA.

Key facts

Status: Ongoing
Initiation date: 2025-12-19
Report date: 2026-01-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2026