United StatesTyber Medical is recalling VOLT Wrist Treatment System distal radius plates: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft Left Standard 139mm (Model 02.426.681S, UDI-DI 00196449020508, Lot 291294) and 6Hd/14Shaft Left Standard 186mm (Model 02.426.691S, UDI-DI 00196449020522, Lot 291293). The plates were distributed in Pennsylvania and are being recalled because the supplier manufactured anatomical left plates with an incorrect thread orientation.
What's being recalled
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
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
Recalling firm: Tyber Medical, Bethlehem, PA, United States.
How to identify it
Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294; Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293
The hazard
The supplier manufactured anatomical left plates with an incorrect thread orientation.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the state of PA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)