Howmedica recalls left small-PCA inserts (product #6637-0-631) manufactured over 5 years ago due to potential oxidation in UHMWPE material. Affected implants may have reduced durability. Contact Howmedica for details.
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 recalls knee replacement implants (left small-PCA inserts) made more than 5 years ago because the material can oxidize over time, potentially reducing durability. This affects patients who received implants from specific lot numbers.
The UHMWPE material in these implants can oxidize over time, especially after 5 years of use. Oxidation may weaken the material, potentially reducing the implant's durability and longevity.
Patients who received knee replacement implants using the recalled left small-PCA inserts (product #663:0-631) from lot numbers 36272501, 42380501, or 42771601. Those with implants made more than 5 years ago are most at risk.
Check if your knee replacement implant has the product number 6637-0-631 and was manufactured with lot numbers 36272501, 42380501, or 42771601. The implant is intended for knee replacement procedures.
Identify your implant's product number (6637-0-631) and lot numbers (36272501, 42380501, 42771601) to confirm if it's affected.
The UHMWPE material in these implants can oxidize over time, especially after 5 years of use, potentially reducing durability.
Check your implant's product number and lot numbers to see if it's affected. Contact Howmedica for further instructions.
The recall is due to potential material degradation over time, but there are no immediate safety risks. The implant may become less durable than expected.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0910-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0910-2024 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.