Medtronic Recalls Vertex Select Multi Axial Screws Due to Length Discrepancy
Medtronic is recalling 83 Vertex Select Multi Axial Screws because the product length is shorter than labeled. The recall covers units distributed in California and Michigan.
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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific defect is a dimensional discrepancy (length shorter than labeled), which is a nonconformance issue rather than a direct contamination or structural failure leading to immediate severe injury.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 83 units of Vertex Select Multi Axial Screws, size 4.0 x 38mm, Lot H5517628. The recall was initiated because the product length was measured shorter than the length specified on the label.
The affected products were distributed nationwide in the United States, specifically in the states of California and Michigan. The product number is 6958838 and the UDI is 00613994354686.
Healthcare providers and patients should check their inventory or medical records for this specific lot number and product size. If the product is found, it should be removed from use and returned to the manufacturer or the distributor in accordance with the recall instructions.
The recalled product
- Product
- VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 83
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)
- Product no. 6958838. UDI: 00613994354686.
Distribution
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