Howmedica recalls PS Lipped Tibial Insert Assay Duracon knee replacement implants with product number 6742-1-411 due to potential oxidation in older units. Affected items may have reduced material properties.
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 PS Lipped Tibial Insert Assay Duracon knee replacement implants that were manufactured with UHMWPE raw material over 5 years old. This could lead to reduced material properties due to oxidation, potentially affecting implant performance.
The UHMWPE raw material used in the implant can oxidize over time, especially if the product is more than 5 years old. Oxidation may weaken the material, potentially affecting the implant's performance and longevity.
Patients who received this specific knee replacement implant from Howmedica are likely affected. Those with implants manufactured over 5 years ago may be at higher risk due to potential oxidation.
Check for product number 6742-1-411 on the implant. The recall applies to units manufactured over 5 years ago with lot number 584223.
Identify the product number (6742-1-411) and lot number (584223) on the implant.
No, this recall specifically applies to PS Lipped Tibial Insert Assay Duracon implants with product number 6742-1-411 and lot number 584223 manufactured over 5 years ago.
The recall does not specify a remedy, so contact Howmedica directly for further instructions.
The recall states that products over 5 years old may have elevated oxidation levels, but the exact duration is not specified.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0923-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0923-2024 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.
