Lower riskMedical device recall · FDA · Published October 9, 2019
Nextremity Stratum Foot Plating System Screw Recall: Incorrect Screw Type Risk
Nextremity Solutions recalls Stratum Foot Plating System NL LP Screw 3.5x50mm ST (lot M1151) due to possible incorrect screw type and length. Affected users should check their product details.
“Nextremity Stratum Foot Plating System Screw Recall: Incorrect Screw Type Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66857-nextremity-stratum-foot-plating-system-screw-recall-incorrect-screw-type. Based on FDA recall #Z-0534-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0534-2020%22&limit=1).
Nextremity Solutions voluntarily recalled the Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile, due to potential incorrect screw type and length in lot M1151, the FDA said on Oct. 9, 2019. The recall affects 49 units distributed nationwide.
The product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length. The Stratum Foot Plating System is indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments.
Context
GovInfoNow's records show Nextremity Solutions has had six other recalls since Nov. 11, 2019. Other recent recalls of similar products include Synthes 2.4V TAP CORTEX SCREW Recall (Feb. 25, 2026), Tornier Perip Screw Recall (Dec. 19, 2025), and Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025).
How to tell if you have this one
Check for the catalog number STRM-NL-3550ST on the product packaging. Look for the lot number M1151 on the label or documentation. The product is a sterile screw used in foot bone repair procedures.
Brand
Nextremity Solutions
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the catalog number and lot number on the screw packaging to confirm if it matches STRM-NL-3550ST and lot M1151.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0534-2020 (October 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0534-2020 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.