Howmedica recalls certain knee replacement inserts manufactured over 5 years ago due to potential oxidation in UHMWPE material. Affected units may have reduced durability.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Howmedica is recalling knee replacement inserts that were made more than 5 years ago because the material could oxidize over time, potentially reducing their strength and safety.
The insert uses UHMWPE (a type of plastic) that can oxidize when it's older than 5 years. Oxidation weakens the material, which might cause the implant to fail over time, though this is unlikely to cause immediate harm.
Patients who received knee replacements using this specific insert model are likely affected. Those with implants made more than 5 years ago are at slightly higher risk due to potential material degradation.
Check for the product number 6637-0-831 on the insert. Units manufactured more than 5 years ago (lot number 47475901) are affected.
Look for the product number 6637-0-831 and lot number 47475901 on the insert.
The recall is due to potential oxidation in the UHMWPE material after more than 5 years of age, which could affect the insert's durability.
The official notice does not specify a replacement requirement; it only mentions checking the product details.
Check for product number 6637-0-831 and lot number 47475901 on the insert. Units older than 5 years are affected.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0911-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0911-2024 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.