Lower riskMedical device recall · FDA · Published August 28, 2025
Howmedica Osteonics Recalls V40 Stems Due to Label Mix-Up Risk
Howmedica Osteonics recalls two V40 stem implants with potential label mix-ups between model numbers 0580-1-442 and 0580-1-352, risking patient confusion.
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
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Contact the company
📍Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
✎ GovInfoNow plain-language explainer
Howmedica Osteonics is recalling two specific V40 stem implants that may have mixed labels between model numbers 0580-1-442 and 0580-1-352. This could lead to patient confusion about which implant is being used, potentially causing incorrect surgical procedures. Read more at govinfonow.com/recall/51528-howmedica-osteonics-recalls-v40-stems-due-to-label-mix-up.
“Howmedica Osteonics Recalls V40 Stems Due to Label Mix-Up Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51528-howmedica-osteonics-recalls-v40-stems-due-to-label-mix-up. Based on FDA recall #Z-2640-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2640-2025%22&limit=1).
Howmedica Osteonics Corp. recalled EXETER V40 stems due to a potential product mix-up where packages may contain the wrong catalog number, according to the FDA on Aug. 28, 2025.
How to tell if you have it
Brand: Howmedica Osteonics
Product: EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442, Lot Number: A00976
Product: EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352, Lot Number: G8754849
Distribution: United Kingdom
The hazard
The recall involves a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls of similar products include Howmedica SCORPIO Patella Implants Recall (July 30, 2026), EMPOWR 3D KNEE Implants Have Incorrect Labeling - Recall Notice (Jan. 15, 2026), Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and Straumann GM Helix Dental Implant Recall (July 13, 2026).
How to tell if you have this one
Check for the model/catalg number 0580-1-442 with lot number A00976 or 0580-1-352 with lot number G8754849 on the implant packaging or patient label.
Brand
Howmedica Osteonics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Your Implant Labels
Look for the model/catalg number and lot number on your implant packaging or patient label.
How this recall unfolded
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2640-2025 (August 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2640-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.