Howmedica recalls TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM (Catalog #5531-G-312-E) due to possible mislabeling with a different size model. This could lead to incorrect use in knee replacements.
Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
Howmedica is recalling a specific knee replacement component (TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM) because it may be mislabeled with a different size model. Using the wrong size could cause improper knee replacement surgery.
The component may be mislabeled with a different size model (PS #4 13MM), which could lead to incorrect use during knee replacement surgery. This might cause improper fitting or complications if the wrong size is used.
Patients who received this specific knee replacement component (Catalog #5531-G-312-E) during surgery are likely affected. Surgeons and medical teams using this component are at the highest risk.
Check for the catalog number 5531-G-312-E on the component. The product was sold with GTIN: 07613327390698 and lot number JH3AHJ.
Look for the catalog number 5531-G-312-E on the component to confirm it is the correct model.
The component may be mislabeled with a different size model (PS #4 13MM), which could lead to incorrect use during knee replacement surgery.
The correct catalog number is 5531-G-312-E.
Check for the catalog number 5531-G-312-E on the component. The product was sold with GTIN: 07613327390698 and lot number JH3AHJ.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1653-2023 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1653-2023 from Howmedica. 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.
