Howmedica recalls older Scorpio-Flex knee implants (part 72-16-0910) due to potential oxidation in UHMWPE material that may affect performance. Affected units have lot numbers starting with 43103101.
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 older Scorpio-Flex knee implants that may have oxidation issues in the UHMWPE material. This could affect the implant's performance over time, though serious injury risk is not specified in the recall.
The implant's UHMWPE material can oxidize over time, especially in units more than 5 years old. Oxidation may weaken the material, potentially affecting the implant's performance and longevity.
Patients who received the Scorpio-Flex knee implant with part number 72-16-0910 and lot numbers starting with 43103101 are affected. Those with implants older than 5 years may be at slightly higher risk due to potential oxidation.
Check for part number 72-16-0910 and lot numbers starting with 43103101 on the implant. The product is intended for knee replacement surgery and was sold with specific lot numbers.
Look for part number 72-16-0910 and lot numbers starting with 43103101 on the implant.
The recall applies to existing implants with part number 72-16-0910 and lot numbers starting with 43103101, not new implants.
Oxidation in the UHMWPE material can weaken it over time, potentially affecting the implant's performance and longevity.
The recall specifies units over 5 years of age as potentially affected, so implants less than 5 years old are not included.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0885-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0885-2024 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.