FDA-Device2026-01-28Class II

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

Tyber Medical
Hazard

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

Sold states
US Nationwide distribution in the state of PA.
Affected count
100 units
Manufactured in
83 S Commerce Way Ste 310, Bethlehem, PA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1131-2026

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