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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Exeter V40 Stems Recalled for Mislabeled Packaging and Product Mix

Agency Publication Date: September 26, 2025
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Summary

Howmedica Osteonics Corp. (Stryker) is recalling 55 units of its Exeter V40 Stems, which are orthopedic hip implants. This recall was issued because packages labeled as one size/model may actually contain a different size/model, potentially causing a mix-up. This issue may also affect the patient labels used for surgical records.

Risk

If a surgeon selects an implant based on incorrect packaging labels, the patient may receive the wrong size device. This could lead to surgical delays, patient injury, or the need for future revision surgery to correct the error.

What You Should Do

  1. This recall involves Exeter V40 Stems (models 0580-1-442 and 0580-1-352) where the physical product inside the package may not match the catalog and lot numbers printed on the outer label.
  2. Check your inventory for Catalog Number 0580-1-442 with Lot Number A00976 and Catalog Number 0580-1-352 with Lot Number G8754849.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: EXETER V40 STEM 44MM NO 2
Model / REF:
0580-1-442
Lot Numbers:
A00976
UDI:
04546540153319

May contain product labeled as Catalog Number 0580-1-352, lot G8754849.

Product: EXETER V40 STEM 37.5MM NO 0
Model / REF:
0580-1-352
Lot Numbers:
G8754849
UDI:
04546540153241

May contain product labeled as Catalog Number 0580-1-442, lot A00976.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97559
Status: Active
Manufacturer: Howmedica Osteonics Corp.
Sold By: Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 55 units (all OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.