Yukon polyaxial screw component recalled for incorrect laser marking
The Yukon polyaxial screw component in the Yukon Spinal System was recalled because it was incorrectly laser marked with wrong dimensions.
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 involves a minor labeling error (incorrect laser marking) with no reported injuries or illnesses, which aligns with the rubric's definition of moderate severity for minor labeling errors.
Plain-English summary
The Yukon polyaxial screw (catalog number 7601-04026) used in the YUKON Spinal System was recalled because it was incorrectly laser marked with size 5.0 mm diameter and 24 mm length instead of the correct specifications.
The manufacturer K2M, Inc. distributed this component domestically across the United States and internationally to Australia, Canada, the Netherlands, and Singapore. Consumers with this specific component should stop using it immediately and contact their healthcare provider or the manufacturer for guidance on disposal and replacement.
This recall is classified as a minor labeling error with no reported injuries or illnesses, so it falls under moderate severity per the recall rubric.
The recalled product
- Product
- Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
- Manufacturer
- K2M, Inc
- Hazard
Distribution
Distributed nationwide across the United States.
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