Howmedica recalls left small-PCA inserts (part 6637-0-028) manufactured over 5 years ago due to potential oxidation in UHMWPE 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 left small-PCA inserts used in knee replacements that were made more than 5 years ago. These older units could have higher oxidation levels in the UHMWPE material, which might reduce their strength and safety over time.
The insert is made from UHMWPE (a type of plastic) that can oxidize over time. Oxidation causes the material to weaken, which might lead to reduced durability and potential failure in the knee replacement over time.
Patients who received knee replacements using this specific insert model (part number 6637-0-028) made more than 5 years ago are affected. Surgeons and medical facilities that use this part are at risk if they have older units.
Check for the part number 6637-0-028 on the insert. Units manufactured more than 5 years ago (lot number 42771401) are affected. This insert is used in knee replacement surgeries.
Verify the production date by checking the lot number on the insert (42771401).
The product was manufactured using UHMWPE raw material over 5 years of age, which can have elevated oxidation levels that might affect material strength.
Check for part number 6637-0-028 and lot number 42771401 on the insert used in your knee replacement.
The recall does not specify a remedy, so contact Howmedica directly for guidance on next steps.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0906-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0906-2024 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.
