Medtronic CD HORIZON Spinal System Screws Recalled for Incorrect Laser Marking
Medtronic is recalling 47 CD HORIZON Spinal System screws because they are incorrectly laser marked as 5.5 mm diameter when they are actually 5.0 mm.
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, which typically corresponds to a moderate severity where the use of the product may cause temporary or medically reversible health consequences. The specific defect is a labeling error regarding the screw diameter, and no injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 47 units of the Medtronic CD HORIZON Spinal System Multi-Axial Screw for 5.5/6.0mm Rods, reference number 55840005045. The affected units are from lot 0648247W and were distributed in the United States.
The recall was initiated because the screws were incorrectly laser marked on both the screw head and the attached data carrier tag. The markings indicate a 5.5 mm diameter, but the actual screw diameter aligns with 5.0 mm diameter screw size requirements.
This is an FDA Class II recall. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the use of these devices.
The recalled product
- Product
- Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- Affected units
- 47
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)
- lot 0648247W
Distribution
Distribution scope not specified by the agency.
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