Recall Z-1131-2026— Tyber Medical

Name: FDA recall Z-1131-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Class II · Ongoing

Class II FDA medical device recall by Tyber Medical, initiated 2025-12-19. It names one FDA 510(k) clearance: K232652. 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: The supplier manufactured anatomical left plates with an incorrect thread orientation..

Recalling firm: Tyber Medical
Classification: Class II
Status: Ongoing
Initiated: 2025-12-19
Firm location: Bethlehem, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K232652 — Anatomical Plating System (various)Tyber Medical, LLC·cleared 2023-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.