Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Mo
Summary
The FDA issued a Class II for Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Rad by Tyber Medical. Reason: The supplier manufactured anatomical left plates with an incorrect thread orientation..
Details
Source
Device Recall
External ID
Z-1131-2026
Action Date
2026-01-28
Status
Ongoing
Category
device
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
Lot/Code Info: Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;
Quantity Affected: 100 units
Reason for Recall
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Distribution
US Nationwide distribution in the state of PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-19
Company
Bethlehem, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tyber Medical has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tyber Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tyber Medical have FDA actions?
Tyber Medical has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1131-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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