Howmedica Osteonics recalls Series II Tibial Bear Insert (Part 3052-0515) 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 Series II Tibial Bear Inserts for knee replacements that are over 5 years old. Oxidation in the material could weaken the insert over time, potentially affecting the joint replacement's performance.
The insert is made from UHMWPE (a type of plastic) that can oxidize over time. Oxidation causes the material to become weaker, which might lead to reduced performance in the joint replacement.
Patients who have received a Series II Tibial Bear Insert for knee replacement surgery are likely affected. Those with implants over 5 years old are at higher risk due to potential material degradation.
Check if your knee replacement insert has the part number 3052-0515 and was manufactured with lot number WK4PX0. The product was sold for knee replacements and is over 5 years old.
Verify if your insert is over 5 years old by checking the manufacturing date on the product.
The product may have elevated oxidation levels after over 5 years, which can affect its material properties.
Check if your insert is over 5 years old. If so, contact Howmedica Osteonics for further guidance.
The recall is for potential material degradation, but serious injury is not described as a direct risk in normal use.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0873-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0873-2024 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.
