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Lower risk Medical device recall · FDA · Published August 31, 2023

Smith & Neph: Knee Implant Recalled for Wrong Size

Smith & Nephew recalls a specific knee implant model due to being shipped with the wrong size. This could lead to improper fit and potential complications during surgery.

🇺🇸 FDA recall #Z-2621-2023Medical deviceSmith & Nephew ›
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Recalling firmSmith & Nephew Inc6409 E Holmes Rd · Memphis, TN 38141-8310
✎ GovInfoNow plain-language explainer

What happened, in plain English

Smith & Nephew is recalling a specific knee implant model because it was shipped with the wrong size (4N instead of 5N). This could cause improper fit and potential complications during surgery. Read more at govinfonow.com/recall/57411-smith-neph-knee-implant-recalled-for-wrong-size.

Source Summary by GovInfoNow · govinfonow.com/recall/57411-smith-neph-knee-implant-recalled-for-wrong-size · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2621-2023

Cite this page

“Smith & Neph: Knee Implant Recalled for Wrong Size.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57411-smith-neph-knee-implant-recalled-for-wrong-size. Based on FDA recall #Z-2621-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2621-2023%22&limit=1).

Why it’s dangerous

The implant was shipped with the wrong size (4N instead of 5N) as labeled. This mismatch could lead to improper fit during surgery, potentially causing complications.

Who’s affected

Patients who received this specific knee implant model (REF 71421265) are likely affected. Surgeons and medical staff who handled the implant during surgery are at higher risk.

How to tell if you have this one

Check for the product code REF 71421265 on the implant. The implant is for the left knee joint and has a specific UDI/DI number: 00885556234006.

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

What to do — step by step

  1. Check Implant Details

    Verify the product code REF 71421265 and UDI/DI number 00885556234006 on the implant.

Where it went and when

Where it was distributed

Distributed in 7 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: yesCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “OH, CT, TX, NC, CA, NE, NV” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Connecticut, Nebraska, Nevada, North Carolina, Ohio, Texas.

Recall timeline

FDA published this recall 27 days after the firm started it.

1. Firm started the recall: Aug 31, 202312. FDA classified it Class II: Sep 20, 202323. Published in FDA’s Enforcement Report: Sep 27, 202332023
  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

What should I do if I have this implant?

Contact Smith & Nephew directly to confirm if your implant is affected and get further instructions.

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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-2621-2023 (August 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2621-2023 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