Howmedica recalls TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM (Catalog #5532-G-413-E) due to mislabeling that may cause confusion with different sizes. This affects knee replacement implants.
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 implant part (TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM) because it's mislabeled. This could lead to using the wrong size part during surgery, which might cause complications.
The part is mislabeled, meaning it might be confused with a different size (12mm instead of 13mm). Using the wrong size could lead to improper knee replacement surgery, potentially causing complications.
Patients who received this specific knee replacement implant part (Catalog Number: 5532-G-413-E) are likely affected. Surgeons and medical staff who use the part are at risk of using the wrong size during procedures.
Check for the Catalog Number: 5532-G-413-E on the part. This specific implant is used in knee replacements and was sold with Lot Number: 7H8RPL.
Look for the Catalog Number: 5532-G-413-E on the part to confirm it's the correct version.
Yes, using the wrong size could cause complications during knee replacement surgery.
Check the Catalog Number on the part; if it's 5532-G-413-E, it's part of the recall.
The correct part has Catalog Number: 5532-G-413-E and is labeled as TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1654-2023 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1654-2023 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.
