Synthes 4.5mm Condylar Plate Recalled for Restricted Sales Release
Synthes USA is recalling a specific lot of 4.5mm condylar plates that were inadvertently released to a sales consultant restricted for sale.
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, but the source text describes a distribution error (release to a restricted consultant) rather than a product defect or safety hazard, fitting the criteria for a voluntary precautionary recall or minor issue.
Plain-English summary
Synthes USA HQ, Inc. is recalling one unit of the Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER. The product is identified by part number 04.124.406S and lot number 3771678. This medical device is used for buttressing multi-fragmentary distal femur fractures.
The recall was initiated because the plate was inadvertently released to a sales consultant that was restricted for sale. The distribution was limited to the United States, specifically in Colorado.
No specific instructions for consumers or healthcare providers are provided in the source text regarding the return or disposal of the device.
The recalled product
- Product
- Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures…
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 1
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 (2)
- part 04.124.406S
- lot 3771678.
Distribution
Distributed in 1 state:
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