Howmedica Osteonics recalls Trident 0 deg Poly Insert (Part 620-00-32J) 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 Osteon: The Trident 0 deg Poly Insert (Part 620-00-32J) is recalled because older units made with UHMWPE raw material over 5 years old may have elevated oxidation levels. This could affect the material's strength and safety in knee replacements.
The insert uses UHMWPE material that can oxidize over time. Oxidation may weaken the material, potentially affecting its performance in knee replacements. However, the risk is not immediate or severe.
Patients who received this specific knee replacement insert (Part 620-00-32J) from Howmedica Osteonics. Those with implants made over 5 years ago are most at risk.
Check if your knee replacement insert has the part number 620-00-32J. Look for lot number 29518001 on the packaging or label.
Verify if your insert was manufactured more than 5 years ago using the lot number on the packaging.
The product may have elevated oxidation levels in older units, which could affect material properties over time.
Check for lot number 29518001 and part number 620-00-32J on the insert packaging.
The recall does not specify a remedy, so contact Howmedica Osteonics directly for guidance.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0902-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0902-2024 from Howmedica Osteonics. 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.
