Howmedica recalls PS Lipped Tibial Insert Assay Duracon knee replacement implants with product number 6742-1-413 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 are over 5 years old. Oxidation in the UHMWPE material could weaken the implant over time, potentially causing failure.
The implant material (UHMWPE) can oxidize over time, especially in units older than 5 years. Oxidation weakens the material, which could lead to reduced performance or failure of the implant.
Knee replacement patients who own the PS Lipped Tibial Insert Assay Duracon implant with product number 674:1-413. Patients with implants over 5 years old are most at risk.
Check for product number 6742-1-413 on the implant. Lot numbers 559469, 561926, or 584958 indicate affected units. The implant is intended for knee replacement procedures.
Identify the product number (6742-1-413) and lot numbers (559469, 561926, 584958) on the implant.
The product may have elevated oxidation levels in the UHMWPE material after more than 5 years of age, which could weaken the implant over time.
Check the product number and lot numbers on the implant to see if it is affected. The recall does not require immediate action beyond checking details.
The recall does not provide a fix or remedy; affected units should be checked for eligibility.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0924-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0924-2024 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.
