Medtronic Sofamor Danek Recalls Midas Rex Legend Wire Pass Tools
Medtronic Sofamor Danek is recalling 9 Midas Rex Legend wire pass tools because the wire pass hole is missing. The tools were distributed in California, New York, Texas, and Belgium.
What this means for you
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. The defect is a missing component (wire pass hole) that renders the tool non-functional for its intended purpose, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Sofamor Danek USA, Inc. is recalling 9 pieces of the Tool Legend 16cm 2.4 mm wire pass for the Midas Rex Legend Dissecting Tool. These tools are used by surgeons to drill holes. The recall is due to a manufacturing defect where the wire pass hole is not present on the tools.
The affected tools have Catalog Number 16TA24 and Lot Number 0006936810. They were distributed in the states of California, New York, and Texas, as well as in the country of Belgium.
This is a Class II recall. The source text does not report any injuries or illnesses associated with this defect. Surgeons and medical facilities should stop using the affected tools and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
- Hazard
- Affected units
- 9
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)
- Catalog Number: 16TA24
- Lot Number: 0006936810
Distribution
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