← FDA ENFORCEMENT
Z-1132-2026Class II

Tyber Medical

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Tyber Medical
Product type
Device
Status
Ongoing
Report date
2026-01-28
Distribution
US Nationwide distribution in the state of PA.
Firm state
PA
Product quantity
64 units
Initiated by
Voluntary: Firm initiated
Reason for recall

The supplier manufactured anatomical left plates with an incorrect thread orientation.

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →