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Lower risk Medical device recall · FDA · Published September 21, 2020

Smith & Nephew Genesis (GII) Surgical Device Recall: Design Flaw Risk

Smith & Nephew recalls Genesis (GII) surgical devices due to a design flaw in the anterior locking detail that may not meet specifications. Affected models include 71420966 with lot 18JY09702.

🇺🇸 FDA recall #Z-0118-2021Medical deviceSmith & Neph: Inc. ›
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Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804
✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling Genesis (GII) surgical devices used in knee surgery. The recall is because the anterior locking detail may not meet design specifications, which could lead to improper function during surgery. Read more at govinfonow.com/recall/64254-smith-nephew-genesis-gii-surgical-device-recall-design-flaw-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64254-smith-nephew-genesis-gii-surgical-device-recall-design-flaw-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0118-2021

Cite this page

“Smith & Nephew Genesis (GII) Surgical Device Recall: Design Flaw Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64254-smith-nephew-genesis-gii-surgical-device-recall-design-flaw-risk. Based on FDA recall #Z-0118-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2021%22&limit=1).

The FDA announced on September 21, 2020, that Smith & Nephew, Inc. is recalling Genesis (GII) surgical devices because the anterior locking detail does not meet design specifications. The agency classified this as a Class II recall.

How to tell if you have it

  • Brand: Smith & Nephew, Inc.
  • Model: 71420966
  • Lot: 18JY09702

The hazard

The FDA stated that the anterior locking detail of the Genesis (GII) device does not meet its design specifications. The record provides no information regarding incidents or injuries.

Context

GovInfoNow's records show Smith & Nephew, Inc. has 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include the Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026), the Olympus HX-400U-30 Ligating Device Recall (October 30, 2025), and the Genesis Push-In Suture Anchor Recall (December 17, 2025).

How to tell if you have this one

Check for the Genesis (GII) device model 71420966 with lot number 18JY09702. This device is used in patients with absent or incompetent posterior cruciate ligaments or collateral ligaments during knee surgery.

  • Brand
    Smith & Neph: Inc.
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model number 71420966 and lot number 18JY09702 on the device.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 14 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: 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: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of CA, NH, NY, GA, MI, TX, IL, OK, LA, OR, FL, AZ, NJ, MO and the countries of AE. BE, BR, CO, DE, ES, FR, GB, HU, IT, PL, PT, TR.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Hampshire, New Jersey, New York, Oklahoma, Oregon, Texas.

Recall timeline

FDA terminated this recall 5.7 years after the firm started it.

1. Firm started the recall: Sep 21, 202012. FDA classified it Class II: Oct 16, 202023. Published in FDA’s Enforcement Report: Oct 28, 202034. FDA terminated the recall: May 22, 2026420202026
  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.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The recall states the anterior locking detail may not meet design specifications, but no specific safety issue is described that would cause injury in normal use.

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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-0118-2021 (September 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0118-2021 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