Howmedica recalls knee replacement implants (product #6637-0-931) due to potential oxidation in older UHMWPE material affecting safety.
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 recalls certain knee replacement implants that may have oxidized UHMWPE material after 5+ years. This could affect the implant's safety and performance.
The implant material (UHMWPE) can oxidize over time, especially after 5 years. Oxidation may weaken the material, potentially affecting the implant's performance and safety.
Patients who received this specific knee implant model (RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT) from Howmedica. Those with implants over 5 years old may be at slightly higher risk.
Check for the product number 6637-0-931 on the implant. The implant was manufactured with lot number 57403601 and intended for knee replacement.
Look for product number 6637-0-9:1 and lot number 57403601 on the implant.
The recall states that implants over 5 years old may have oxidized UHMWPE material, which could affect safety. However, the risk is not described as causing serious injury.
The recall does not specify a stop-use action. Patients should check if their implant matches the product details and contact Howmedica for guidance.
Check for product number 6637-0-931 and lot number 57403601 on the implant. This specific model was recalled due to potential oxidation after 5+ years.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0913-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0913-2024 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.
