Long distal radius plates recalled over an incorrect thread orientation
Tyber Medical is recalling 64 units VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a manufacturing thread-orientation error with no stated consequence or reported harm.
Plain-English summary
The VOLT Wrist Treatment System 2.4/2.7 2-Column Distal Radius Plate, 6 head, 14 shaft, standard left, 186mm, model/catalog number 02.426.691S, is being recalled by Tyber Medical.
The reason given in the enforcement record is that the supplier manufactured anatomical left plates with an incorrect thread orientation.
The record lists 64 units under model 02.426.691S, UDI-DI 00196449020522, lot number 291293. The record gives distribution as US nationwide in the state of Pennsylvania. The FDA has classified the action as Class II.
The record names no consequence and reports no injuries. Facilities should quarantine the affected lot and follow Tyber Medical's instructions.
The recalled product
- Product
- 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
- Manufacturer
- Tyber Medical
- Hazard
- manufacturing-defect
- thread-orientation
- supplier-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No: 02.426.691S
- UDI-DI: 00196449020522
- Lot Number: 291293
Distribution
Distributed nationwide across the United States.
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