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Lower risk Medical device recall · FDA · Published June 27, 2022

Smith & Nephew Genesis II Tibial Baseplates Recalled Due to Mispackaging

Smith & Nephew recalls two Genesis II Non-Porous Tibial Baseplates (Size 5 Right and Size 4 Left) due to mispackaging. The inner tray matches the inner tray but does not match the outer box label and chart sticks.

🇺🇸 FDA recall #Z-1418-2022Medical deviceSmith & Nephew ›
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Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804
✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling two specific Genesis II Non-Porous Tibial Baseplates because they were mispackaged. The inner tray matches the inner tray but does not match the outer box label and chart sticks. This could lead to incorrect use in medical procedures. Read more at govinfonow.com/recall/60418-smith-nephew-genesis-ii-tibial-baseplates-recalled-due-to-mispackaging.

Source Summary by GovInfoNow · govinfonow.com/recall/60418-smith-nephew-genesis-ii-tibial-baseplates-recalled-due-to-mispackaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1418-2022

Cite this page

“Smith & Nephew Genesis II Tibial Baseplates Recalled Due to Mispackaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60418-smith-nephew-genesis-ii-tibial-baseplates-recalled-due-to-mispackaging. Based on FDA recall #Z-1418-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1418-2022%22&limit=1).

The FDA announced on June 27, 2022, that Smith & Nephew, Inc. voluntarily recalled Genesis II Non-Porous Tibial Baseplates due to mispackaging hazards. The devices were swapped, meaning the inner tray contents did not match the outer box labels or chart sticks.

How to tell if you have it

  • Brand: Smith & Nephew
  • Product: Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186, Lot #21DM14954S, exp. October 2030, UDI #03596010206350
  • Product: Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166, Lot #21FM13870A, exp. October 2030, UDI #03596010206268
  • Distribution: US Nationwide in AZ, CA, GA, KS, LA, MN, MI, MO, MS, NC, NJ, NY, OR, SC, TN, VA, WA, and WI

The hazard

The product was mispackaged because the devices within the inner tray were swapped. The devices matched the inner tray but did not match the outer box label or the chart sticks.

Context

GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025). Other recent recalls of similar products include Howmedica Triathlon Baseplate Size 3 Recall (May 19, 2026), Howmedica Triathlon Baseplate Size 4 Recall (May 19, 2026), and U2 Total Knee System Femoral Offset Bushing Recall (March 19, 2026).

How to tell if you have this one

Check for the product numbers: 71420186 (Size 5 Right, Lot #21DM14954S, exp. October 2030) or 71420166 (Size 4 Left, Lot #21FM13870A, exp. October 2030). The inner tray matches the inner tray but does not match the outer box label and chart sticks.

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

What to do — step by step

  1. Check Product Labels

    Look for the product numbers 71420186 (Size 5 Right) or 71420166 (Size 4 Left) on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 18 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO, MS, NC, NJ, NY, OR, SC, TN, VA, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Georgia, Kansas, Louisiana, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Oregon, South Carolina, Tennessee, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 3.7 years after the firm started it.

1. Firm started the recall: Jun 27, 202212. FDA classified it Class II: Jul 20, 202223. Published in FDA’s Enforcement Report: Jul 27, 202234. FDA terminated the recall: Mar 25, 2026420222026
  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-1418-2022 (June 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1418-2022 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