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Lower risk Medical device recall · FDA · Published December 16, 2019

Nextremity Stratum Lapidus Plate Recall: Wrong Plate Type Risk

Nextremity Solutions recalls Stratum Lapidus Plate (Part No. STRM-LAP-SMR) due to incorrect plate type. This could cause improper bone fixation. Affected units have UDI 00817701025467.

🇺🇸 FDA recall #Z-1127-2020Medical deviceNextremity Solutions ›
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Recalling firmNextremity Solutions6210 N Buffalo St · Warsaw, IN 46580
✎ GovInfoNow plain-language explainer

Nextremity Solutions is recalling a specific Stratum Lapidus Plate model because it contains a left plate instead of the labeled right plate. This mismatch could lead to improper bone fixation during medical procedures. Read more at govinfonow.com/recall/66317-nextremity-stratum-lapidus-plate-recall-wrong-plate-type-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66317-nextremity-stratum-lapidus-plate-recall-wrong-plate-type-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1127-2020

Cite this page

“Nextremity Stratum Lapidus Plate Recall: Wrong Plate Type Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66317-nextremity-stratum-lapidus-plate-recall-wrong-plate-type-risk. Based on FDA recall #Z-1127-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1127-2020%22&limit=1).

The FDA announced on 2019-12-16 that Nextremity Solutions is recalling the Stratum Lapidus Plate - Small Rt due to labeling errors. The package indicates a right plate but contains a left plate, posing a risk of incorrect surgical use. This voluntary Class II recall involves 40 units distributed domestically.

How to tell if you have it

  • Brand: Nextremity Solutions
  • Product: Stratum Lapidus Plate - Small Rt
  • Part No.: STRM-LAP-SMR
  • UDI: 00817701025467
  • Lot: M1502

The hazard

The product contains a different plate than indicated by the package labeling. Specifically, the item is labeled as a right plate but actually contains a left plate.

Context

GovInfoNow's records show Nextremity Solutions has had 6 other recalls since 2019-10-09. Other recent recalls of similar products include Waldemar Link Endo-Model Tibial Plateau Recall (2026-07-06), restor3d Veritas Standard Glenoid Baseplate Recall (2026-06-30), and Howmedica Triathlon Baseplate Size 3 Recall (2026-05-19).

How to tell if you have this one

Check for the product name 'Stratum Lapidus Plate - Small Rt' with part number STRM-LAP-SMR. Affected units have a unique device identifier (UDI) starting with 00817701025467.

  • Brand
    Nextremity Solutions
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the plate's part number and unique device identifier (UDI) to confirm if it matches the recalled model.

Where it went and when

Where it was distributed

Distributed in 22 states.

Alaska: not listedAKMaine: yesMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic distribution to AL, CA, FL, GA, ID, IL, IA, KY, LA, ME, MA, MI, MN, MS, NE, NJ, NY, OH ,OK, OR, TX, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Florida, Georgia, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Texas, Washington.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: Dec 16, 201912. FDA classified it Class II: Feb 10, 202023. Published in FDA’s Enforcement Report: Feb 19, 202034. FDA terminated the recall: Sep 8, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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-1127-2020 (December 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1127-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA