Nextremity Stratum MDS Screw 3.5x5: Components 2mm Shorter Than Labeled
Nextremity Solutions recalls Stratum MDS Screw 3.5x50mm ST (part number STRM-MDS-3550ST) due to components being 2mm shorter than labeled. Affected units include lot M1268 with UDI 00817701023173.
Lower-risk recall
Components 2mm shorter than indicated on the package label
Contact the company
What happened, in plain English
Nextremity Solutions is recalling Stratum MDS screws that are 2mm shorter than labeled. This could cause improper fit in applications requiring precise dimensions, though the risk is low for most users. Read more at govinfonow.com/recall/66539-nextremity-stratum-mds-screw-3-5x5-components-2mm-shorter-than.
Source Summary by GovInfoNow · govinfonow.com/recall/66539-nextremity-stratum-mds-screw-3-5x5-components-2mm-shorter-than · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0778-2020
Cite this page
“Nextremity Stratum MDS Screw 3.5x5: Components 2mm Shorter Than Labeled.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66539-nextremity-stratum-mds-screw-3-5x5-components-2mm-shorter-than. Based on FDA recall #Z-0778-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0778-2020%22&limit=1).
Why it’s dangerous
The screws are 2mm shorter than labeled, which may lead to improper installation or fit in applications requiring precise measurements. This could cause misalignment or failure in mechanical assemblies but does not pose a direct safety risk in normal use.
Who’s affected
Users of Stratum MDS screws with part number STRM-MDS-3550ST, particularly those in precision assembly or engineering applications where exact dimensions matter. Most consumers are unlikely to be affected.
How to tell if you have this one
Check for part number STRM-MDS-3550ST on the screw packaging. Affected units were sold with lot number M1268 and unique device identifier UDI 00817701023173.
- Brand
Nextremity Solutions- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0776-2020 | Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST; Lot Number: M1266 UDI: 00817701023159 | 87 units |
| Z-0777-2020 | Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST; Lot Number: M1267 UDI: 00817701023166 | 86 units |
| Z-0778-2020 | Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST; Lot Number: M1268 UDI: 00817701023173 | 86 units |
What to do — step by step
Check Product Label
Look for part number STRM-MDS-3550ST on the screw packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to do anything with the screw?
The recall does not require immediate action; check the label to confirm if you have the affected model.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0778-2020 (November 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0778-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.