Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy
Nextremity Solutions is recalling 86 Stratum MDS Screws because the components are 2mm shorter than indicated on the package label.
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, and the hazard involves a dimensional discrepancy (2mm shorter) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Nextremity Solutions is recalling 86 units of the Stratum MDS Screw 3.5x48mm ST (Part Number: STRM-MDS-3548ST). The recall was initiated because the components are 2mm shorter than indicated on the package label.
The affected products are identified by Lot Number M1267 and UDI 00817701023166. The recall is classified as Class II by the U.S. Food and Drug Administration. The products were distributed nationwide.
Consumers and healthcare providers should stop using the affected screws and contact Nextremity Solutions for further instructions.
The recalled product
- Product
- Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
- 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: M1267 UDI: 00817701023166
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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