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 that could affect material properties. This could impact the product's performance in knee replacements.
The poly insert uses UHMWPE (ultra-high molecular weight polyethylene) that can oxidize over time. Oxidation may weaken the material, potentially affecting its performance in knee replacements. However, the hazard is not described as causing immediate injury or failure in normal use.
Patients who received this specific poly insert for knee replacement surgery are likely affected. Those with implants made from this part number and manufactured over 5 years ago are at risk.
Check if your knee replacement uses the Howmedica Osteonics Trident 0 deg Poly Insert (Part Number 620-00-32J). The lot number is 29518001 for affected items.
Identify if your knee replacement uses the Howmedica Osteonics Trident 0 deg Poly Insert (Part Number 620-00-32J).
The product may have elevated oxidation levels in UHMWPE raw material over 5 years old, which could affect material properties.
The recall does not specify a remedy, so check with your surgeon or Howmedica Osteonics for guidance.
Affected items have the lot number 29518001 and are the Howmedica Osteonics Trident 0 deg Poly Insert (Part Number 620-00-32J).
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0903-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0903-2024 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.
