Howmedica Osteonics recalls Trident 0 deg Poly Insert (Part 620-00-28J) 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 Osteonics is recalling their Trident 0-degree poly insert for knee replacements that are over 5 years old. This could lead to reduced material properties in the insert due to oxidation.
The poly insert is made from UHMWPE material that can oxidize over time. Oxidation may weaken the material, potentially affecting the implant's performance in the knee joint.
Patients who received this specific knee replacement insert (Part Number 620-00-28J) from Howmedica Osteonics. Those with implants over 5 years old are most at risk.
Check if your knee replacement insert has the part number 620-00-28J and was manufactured with a lot number starting with 38059601. The product is intended for knee replacements and is over 5 years old.
Identify if your insert has part number 620-00-28J and lot number starting with 38059601.
The product may have elevated oxidation levels after over 5 years of age, which can affect its material properties.
The recall record does not specify a remedy, so contact Howmedica Osteonics for further instructions.
The recall indicates potential material property changes due to oxidation, but no immediate safety risks are described.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0901-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0901-2024 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.
