Howmedica recalls 42mm UNITRAX Endoprosthesis Head Components due to potential size mismatch between packaging labels and actual implants. This affects hip replacement surgeries.
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
Howmedica is recalling 42mm UNITRAX Endoprosthesis Head Components used in hip replacements because the size on the packaging might not match the actual implant. This mismatch could lead to improper fitting during surgery.
The packaging label might show a different size than the actual implant. This mismatch could cause improper fitting during hip replacement surgery if the wrong size is used.
Patients who received a 42mm UNITRAX Endoprosthesis Head Component for hip replacement surgery. Surgeons and medical facilities using these components are most at risk.
Check the packaging label for the size (42mm, 43mm, or 38mm) and the catalog number 6942-5-042. The lot numbers 4615EX, HE645D, and 8A399N are also associated with this recall.
Verify the size on the packaging label matches the actual implant (42mm, 43mm, or 38mm).
The recall is for potential size mismatch, which could affect surgery fit but does not pose an immediate risk to patients.
Check the packaging label for the size and catalog number to confirm if it's part of this recall. Contact Howmedica for further guidance.
Look for the catalog number 6942-5-042 and lot numbers 4615EX, HE645D, or 8A399N on the packaging.
We’ve drafted a message you can send Howmedica Osteon: 42mm UNITRAX Head to request your refund or repair — edit it as you like.
Subject: Recall Z-2371-2024 — Howmedica Osteon: 42mm UNITRAX Head Howmedica Osteon: 42mm UNITRAX Head Hello, I own a Howmedica Osteon: 42mm UNITRAX Head that is covered by recall Z-2371-2024 from Howmedica Osteon: 42mm UNITRAX Head. 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.
