Howmedica recalls older models of knee replacement inserts (part 6637-0-231) due to potential oxidation in UHMWPE material that could affect joint function. Affected units have specific lot numbers and were sold between 2019-2024.
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 older knee replacement inserts that may have oxidation issues in the UHMWPE material. This could affect the insert's performance and long-term joint health if the product is used beyond its intended lifespan.
The insert's UHMWPE material may oxidize over time, especially after 5 years of use. Oxidation can weaken the material, potentially causing joint instability or reduced mobility if the insert is used beyond its intended lifespan.
Patients who received the LEFT LARGE-PCA insert (part number 6637-0-231) with lot number 42787901 are most at risk. This product was sold between 2019 and 2024.
Check for the part number 6637-0-231 on the insert. The affected units were sold between 2019 and 2024 with lot number 42787901.
Look for part number 6637-0-231 and lot number 42787901 on the insert.
The recall is for potential oxidation in the UHMWPE material that could affect long-term joint function, but it does not pose an immediate risk of injury or harm.
Check for part number 6637-0-231 and lot number 42787901 on the insert. The product was sold between 2019 and 2024.
The recall does not require immediate action; check the insert details to confirm if it is affected.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0908-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0908-2024 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.