Synthes VA-LCP Distal Radius Plate Labeling Recall
Synthes (USA) Products LLC is recalling 119,891 units of 2.4mm VA-LCP Two Column Volar Distal Radius Plates due to a labeling error in the US Technique guide.
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: The recall is classified as FDA Class II and involves a labeling error that creates a potential for improper device use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Synthes (USA) Products LLC is initiating a Field Safety Correction for the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The recall involves 119,891 units of the product, identified by part number J8301-F, which were distributed nationwide.
The recall was initiated because the US Technique guide incorrectly lists the 1.2 Nm Torque Limiting Attachment (TLA) as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column Volar Distal Radius Plate. The source text notes that this labeling error creates a potential for the VA locking screw to be driven through the 2.4mm plate, although the specific consequence is not fully detailed in the provided text.
The affected product is intended for the fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. Healthcare providers and facilities that have received these units should stop using the affected plates and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
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 (1)
- Part number J8301-F
Distribution
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