Howmedica Osteonics recalls certain knee replacement inserts manufactured over 5 years ago due to potential oxidation in UHMWPE material. Affected products have Product Number 6637-0-928 and Lot Numbers starting with 41875401.
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 Osteonics is recalling knee replacement inserts that were manufactured more than 5 years ago because the UHMWPE material may have oxidized, potentially affecting its properties. This could lead to complications with the implant over time.
The UHMWPE material in the knee replacement insert can oxidize over time, especially if the product is more than 5 years old. Oxidation may weaken the material, potentially causing issues with the implant's performance or longevity.
Patients who received knee replacements using this specific insert model (Product Number 6637-0-928) are likely affected. Those with implants manufactured over 5 years ago are at slightly higher risk due to potential material degradation.
Check for Product Number 6637-0-928 on the insert. The lot numbers start with 41875401. This insert was intended for knee replacement surgeries and manufactured over 5 years ago.
Look for Product Number 6637-0-928 and Lot Numbers starting with 41875401 on the insert.
The UHMWPE material in the insert may oxidize over time, especially if the product is more than 5 years old, which could affect its material properties.
Check for Product Number 6637-0-928 and Lot Numbers starting with 41875401 on the insert. This insert was manufactured over 5 years ago.
The recall does not specify a remedy, so contact Howmedica Osteonics directly for guidance.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0912-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0912-2024 from Howmedica Osteonics. 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.
