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Lower risk Medical device recall · FDA · Published May 19, 2021

Smith & Nephew Knee Implant Recall: Surface Damage Risk

Smith & Nephew recalls specific knee implant components due to surface damage from manufacturing. Affected units have a unique reference number and size. Consumers should contact the manufacturer for details.

🇺🇸 FDA recall #Z-1951-2021Medical deviceSmith & Nephew ›
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Contact the company

Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804
✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling a specific knee implant component that may have surface damage from manufacturing. This could affect the implant's performance and safety during surgery. Read more at govinfonow.com/recall/62510-smith-nephew-knee-implant-recall-surface-damage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62510-smith-nephew-knee-implant-recall-surface-damage-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1951-2021

Cite this page

“Smith & Nephew Knee Implant Recall: Surface Damage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62510-smith-nephew-knee-implant-recall-surface-damage-risk. Based on FDA recall #Z-1951-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1951-2021%22&limit=1).

Smith & Nephew, Inc. voluntarily recalled one unit of its LEGION Posterior Stabilized OXINIUM Femoral Component on May 19, 2021, due to surface damage from a manufacturing process error, the FDA said.

How to tell if you have it

  • Brand: Smith & Nephew
  • Product: LEGION Posterior Stabilized OXINIUM Femoral Component
  • REF: 71421216
  • Size: 6
  • Side: Left
  • Lot: 20HM17607

The hazard

The device components experienced a manufacturing process error that resulted in surface damage from product handling.

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 Howmedica Osteonics Recalls Knee Implant Components Due to Oxidation Risk (July 30, 2026), Howmedica SCORPIO C-DOME/PATELLA Implants Recall: Risk of Excessive Wear Debris (July 30, 2026) and Howmedica SCORPIO Patella Implants Recall: Oxidation Risk (July 30, 2026).

How to tell if you have this one

Check for the reference number REF 71421216, size 6, left side, nonporous femoral component, and lot number 20HM17607 on the implant. This component is used in cemented knee replacements.

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

What to do — step by step

  1. Contact Manufacturer

    Reach out to Smith & Nephew directly for specific guidance on affected units and next steps.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Nebraska, New York, Texas.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: May 19, 202112. FDA classified it Class II: Jun 24, 202123. Published in FDA’s Enforcement Report: Jun 30, 202134. FDA terminated the recall: Apr 14, 2023420212023
  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-1951-2021 (May 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1951-2021 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