Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy
Nextremity Solutions is recalling 87 Stratum MDS Screws because they are 2mm shorter than the length indicated on the package label.
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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling discrepancy regarding product dimensions.
Plain-English summary
Nextremity Solutions is recalling 87 units of Stratum MDS Screw 3.5x46mm ST (Part Number: STRM-MDS-3546ST). The recall is being conducted because the components are 2mm shorter than the length indicated on the package label.
The affected products are identified by Lot Number M1266 and UDI 00817701023159. The recall is classified as Class II by the U.S. Food and Drug Administration.
The source text does not specify the distribution scope, specific dates, or instructions for consumers. Healthcare providers and patients should verify the lot number and UDI of their devices against the recall information.
The recalled product
- Product
- Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
- Manufacturer
- Nextremity Solutions
- Hazard
- Affected units
- 87
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 Number: M1266 UDI: 00817701023159
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Nextremity Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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