Howmedica recalls DURATION A-P LIPPED TIB.INSERT-DURAC knee implants manufactured over 5 years ago due to potential oxidation in UHMWPE material. Affected units have Product Number 6642-1-911 and Lot Numbers 56000801, 57491601.
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 implants made with UHMWPE material that are older than 5 years. Oxidation in this material could affect its properties, though the recall doesn't specify immediate injury risk.
The UHMWPE material in the implant can oxidize over time, which may weaken its structural properties. This could lead to reduced implant performance, but the recall does not indicate a risk of injury or failure in normal use.
Patients who received this specific knee implant model from Howmedica are likely affected. Those with implants manufactured over 5 years ago are at slightly higher risk due to potential material changes.
Check for Product Number 6642-1-911 and Lot Numbers 56000801 or 57491601 on the implant packaging. This product was sold for knee replacements and manufactured over 5 years ago.
Look for Product Number 6642-1-911 and Lot Numbers 56000801 or 57491601 on the implant packaging.
The recall is due to potential oxidation in the UHMWPE material after more than 5 years of manufacture, which could affect its material properties.
The recall does not indicate a risk of injury or failure in normal use. Oxidation may impact material properties but the hazard is not described as causing injury.
Check the product details on the implant packaging to see if it matches the recalled model. If it does, contact Howmedica for further instructions.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0917-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0917-2024 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.