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.
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.
The recall involves a potential mix-up between two specific model numbers on the packaging and patient labels. This could lead to confusion about which implant is being used during surgery, potentially causing incorrect procedures.
Patients who received the recalled V40 stems (44mm model 0580-1-442, lot A00976 or 37.5mm model 0580-1-352, lot G8754849) are most at risk due to possible label mix-ups.
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.
Look for the model/catalg number and lot number on your implant packaging or patient label.
The recall affects two models: 1) EXETER V40 STEM 44MM NO 2 with model/catalg number 0580-1-442 and lot number A00976, and 2) EXETER V40 STEM 37.5MM NO 0 with model/catalg number 0580-1-352 and lot number G8754849.
The recall states a potential label mix-up, but no specific risk of injury is mentioned. This is considered a low-risk situation.
Check your implant's model/catalg number and lot number against the specific numbers listed in the recall: 0580-1-442 with lot A00976 or 0580-1-352 with lot G8754849.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-2640-2025 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-2640-2025 from Howmedica Osteonics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.