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 wrist plates (Model 02.426.681S, Lot 291294) were manufactured with incorrect thread orientation. This defect could affect proper plate installation during wrist surgery. No injuries have been reported.
- If you received or used plates from Lot 291294, contact Tyber Medical or your surgeon immediately
- Do not use affected plates for new procedures
- Check any recent wrist surgeries using this product and report concerns to your doctor
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
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-1131-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.