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Lower risk Medical device recall · FDA · Published December 30, 2021

Howmedica Exeter V40 Cemented Hip Stem Recall: Label Mix Risk

Howmedica recalls Exeter V40 Cemented Hip (150mm) Stem (Part 0580-1-440) due to potential label mix with 125mm stem. Affected units may be used incorrectly.

🇺🇸 FDA recall #Z-0652-2022Medical deviceHowmedica ›
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Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
✎ GovInfoNow plain-language explainer

What happened, in plain English

Howmedica is recalling Exeter V40 Cemented Hip (15:0mm) Stems with part number 0580-1-440 because there's a risk of confusing them with the smaller 125mm version. This could lead to improper use during hip replacement surgery. Read more at govinfonow.com/recall/61323-howmedica-exeter-v40-cemented-hip-stem-recall-label-mix-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61323-howmedica-exeter-v40-cemented-hip-stem-recall-label-mix-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0652-2022

Cite this page

“Howmedica Exeter V40 Cemented Hip Stem Recall: Label Mix Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61323-howmedica-exeter-v40-cemented-hip-stem-recall-label-mix-risk. Based on FDA recall #Z-0652-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0652-2022%22&limit=1).

Why it’s dangerous

The recall is for a potential label mix between the 150mm and 125mm stems. If the wrong size is used in surgery, it could cause improper hip joint alignment or complications during the procedure.

Who’s affected

Patients who received this specific hip stem during surgery are likely affected. Surgeons using the product for hip replacements may also be at risk if they mix up the sizes.

How to tell if you have this one

Check for part number 0580-1-440 on the stem. The product was sold with lot number G7900352 and GTIN 04546540153296. This specific stem is used in hip replacements.

  • Brand
    Howmedica
  • Product
    Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    The product was distributed to the following US states: MI
Recall numberProduct, codes & lotsQuantity
Z-0651-2022Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044; GTIN: 04546540509048; Lot G790023659 devices
Z-0652-2022Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440; GTIN: 04546540153296; Lot G790035258 devices
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for part number 0580-1-440 on the stem to confirm it's the recalled model.

Where it went and when

Where it was distributed

Distributed in Michigan.

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: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: 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: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “The product was distributed to the following US states: MI” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Michigan.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Dec 30, 202112. FDA classified it Class II: Feb 17, 202223. Published in FDA’s Enforcement Report: Feb 23, 202234. FDA terminated the recall: Mar 14, 2024420212024
  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

Do I need to stop using this product?

No action is required for the product itself. The recall is to prevent confusion with the smaller 125mm stem during surgery.

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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-0652-2022 (December 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0652-2022 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