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Lower risk Medical device recall · FDA · Published July 16, 2020

Smith & Nephew Tibial Knee Prosthesis Recall: Internal Material Defect Risk

Smith & Nephew recalls specific lots of Tibial knee prosthesis models due to potential internal material defects that could affect safety. Affected units include model numbers 71420164, 71420166, 71420184 and listed lot numbers.

🇺🇸 FDA recall #Z-2774-2020Medical deviceSmith & Nephew ›
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Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804
✎ GovInfoNow plain-language explainer

What happened, in plain English

Smith & Nephew is recalling specific lots of Tibial knee prosthesis models (71420164, 71420166, 71420184) because some units may have internal material defects from inconsistent raw material processing. This could lead to potential safety issues during use, so affected users should check their product details. Read more at govinfonow.com/recall/64704-smith-nephew-tibial-knee-prosthesis-recall-internal-material-defect-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64704-smith-nephew-tibial-knee-prosthesis-recall-internal-material-defect-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2774-2020

Cite this page

“Smith & Nephew Tibial Knee Prosthesis Recall: Internal Material Defect Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64704-smith-nephew-tibial-knee-prosthesis-recall-internal-material-defect-risk. Based on FDA recall #Z-2774-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2774-2020%22&limit=1).

Why it’s dangerous

The recall is due to an inconsistency in the raw material process that may result in units with non-homogenous material defects. These defects could potentially affect the structural integrity of the prosthesis during use, though the specific risk level is not described as severe.

Who’s affected

Patients who have received the recalled Tibial knee prosthesis models (71420164, 71420166, 71420184) and the listed lot numbers. Orthopedic surgeons and medical staff who use these models are also at risk if they have the affected units.

How to tell if you have this one

Check if your Tibial knee prosthesis model is 71420164, 71420166, or 71420184. Also, verify the lot numbers listed in the recall notice, which include specific combinations of numbers starting with 19MT, 20AT, 20BT, and G1923903 through G1925742.

  • Brand
    Smith & Nephew
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify your prosthesis model and lot number to see if it matches the recalled items listed in the notice.

Where it went and when

Where it was distributed

Distributed in 25 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: not listedILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic Distribution: AL, LA ,MN, KY, AR, MN, GA, TX, WI, NJ, NC, CT, NY, OH, IA, IN, NC, MA, SC, NV, CT, WV, NY, OH, MN, MI, SC, TN, FL, AZ, PA and MO. International Distribution: Austria, Belgium, China, Canada, Switzerland, Colombia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, Connecticut, Florida, Georgia, Indiana, Iowa, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 34 days after the firm started it.

1. Firm started the recall: Jul 16, 202012. FDA classified it Class II: Aug 7, 202023. Published in FDA’s Enforcement Report: Aug 19, 202032020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

Do I need to stop using this prosthesis immediately?

The recall does not require immediate discontinuation; affected users should check their product details to confirm if they are in the recall list.

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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-2774-2020 (July 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2774-2020 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