FDA-Device2026-01-28Class IIPROCESSING DEFECT
Tyber Medical VOLT wrist plate recalled for incorrect thread orientation
What this means
Tyber Medical's VOLT wrist treatment system left distal radius plates (model 02.426.691S, lot 291293) were manufactured with incorrect thread orientation. This defect could affect proper plate positioning and screw fixation during wrist surgery. Approximately 64 units were distributed nationwide.
- If you received this plate (model 02.426.691S, lot 291293), do not use it
- Contact Tyber Medical for instructions on return or replacement
- Check your inventory against the affected lot number
The agency's original wording
Hazard
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Intended for
Adults
Illnesses reported
None reported
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-1132-2026Want us to check the next one for you?
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