Howmedica recalls knee replacement TIBIAL BEARING INSERTS made over 5 years ago due to potential oxidation in UHM:PE material. Affected units may have reduced durability.
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 TIBIAL BEARING INSERTS that were manufactured more than 5 years ago. Oxidation in the UHMWPE material could reduce the insert's durability, potentially causing failure during use.
The UHMWPE material in the insert can oxidize over time, especially in units older than 5 years. Oxidation weakens the material, which may lead to reduced durability and potential failure during knee replacement procedures.
Knee replacement surgery patients who received the TIBIAL BEARING INSERT SERIES P-S I ASSY with lot number 59065701. Patients using these inserts are at risk if the material degrades over time.
Check for the product number 7291-0324 and lot number 59065701 on the insert. These inserts are intended for knee replacements and were sold with the GTIN 04546540117144.
Look for product number 7291-0324 and lot number 59065701 on the insert.
The UHMWPE material in the insert can oxidize over time, especially in units older than 5 years. Oxidation weakens the material, which may lead to reduced durability and potential failure during knee replacement procedures.
No, the recall does not require immediate discontinuation. The product is safe for use if it is less than 5 years old.
Check for product number 7291-0324 and lot number 59065701 on the insert.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0926-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0926-2024 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.
