Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy
Nextremity Solutions is recalling 86 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 temporary or medically reversible adverse health consequence. The hazard is a dimensional discrepancy (2mm shorter) rather than a high-risk pathogen or structural failure leading to immediate severe injury, fitting the Moderate category for a voluntary precautionary recall of a medical device.
Plain-English summary
Nextremity Solutions is voluntarily recalling 86 units of Stratum MDS Screw 3.5x50mm ST (Part Number: STRM-MDS-3550ST). The recall is due to a manufacturing discrepancy where the components are 2mm shorter than the length indicated on the package label.
The affected products are identified by Lot Number M1268 and UDI 00817701023173. The recall is classified as Class II by the U.S. Food and Drug Administration. The products were distributed nationwide.
Healthcare providers and patients should stop using the affected screws and contact Nextremity Solutions for further instructions or a replacement.
The recalled product
- Product
- Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
- Manufacturer
- Nextremity Solutions
- Affected units
- 86
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: M1268 UDI: 00817701023173
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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