FDA Medical devices recall ·
VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius… recall
- Recall number
- Z-1131-2026
- Date
- (initiated December 19, 2025)
- Company / brand
- Tyber Medical
83 S Commerce Way Ste 310, Bethlehem, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 100 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
The supplier manufactured anatomical left plates with an incorrect thread orientation.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;
Distribution
US Nationwide distribution in the state of PA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1131-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.