Howmedica recalls PS Lipped Tibial Insert Assay Duracon knee replacement implants with product number 6742-1-416 due to potential oxidation in older units. Affected units were sold with specific lot numbers.
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 may have oxidation issues after over 5 years of use. This could affect the material properties and safety of the implant.
The implant material (UHMWPE) can oxidize over time, especially after 5 years of use. Oxidation may weaken the material properties, potentially affecting the implant's performance and safety.
Knee replacement patients who own the PS Lipped Tibial Insert Assay Duracon implant with product number 6742-1-416 and lot numbers 571630, 582549, or 584840 are most at risk.
Check for the product number 6742-1-416 and lot numbers 571630, 582549, or 584840 on the implant packaging or documentation.
Identify the product number and lot numbers on the implant to confirm if it is affected.
The recall is for potential oxidation in older units, which may affect material properties but does not indicate immediate risk of serious injury.
Check the product number and lot numbers to see if it is affected; no specific action is required if it is not in the recalled list.
The recall applies to implants manufactured using UHMWPE raw material over 5 years of age.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0925-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0925-2024 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.
