Distal radius plates recalled over an incorrect thread orientation
Tyber Medical is recalling 100 VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, 10 shaft, standard left, 139mm, model/catalog number 02.426.681S, 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 100 units under model 02.426.681S, UDI-DI 00196449020508, lot number 291294. 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/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
- Manufacturer
- Tyber Medical
- Affected units
- 100
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: 02.426.681S
- UDI-DI: 00196449020508
- Lot Number: 291294
Distribution
Part of a larger recall action
This product is one of 2 recalled by Tyber Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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