FDA-Device2026-01-28Class II
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
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
64 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/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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2026Don't want to check this manually?
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