Howmedica Osteonics recalls SCORPIO TS TIB INSERT knee replacement implants with UHMWPE raw material over 5 years old due to potential oxidation affecting 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 SCORPIO TS TIB INSERT knee replacement implants that were manufactured with UHMWPE raw material more than 5 years old. Oxidation in this material could weaken the implant over time, potentially causing failure during use.
The UHMWPE raw material in the implant can oxidize over time, especially if the implant is more than 5 years old. Oxidation weakens the material, which could lead to implant failure during use. However, this risk is not immediate and does not cause serious injury in normal use.
Knee replacement patients who own the SCORPIO TS TIB INSERT implant with part number 72-4-7518 and lot numbers 9P8360 or AK8393 are affected. Patients using implants older than 5 years since manufacturing are at higher risk.
Check for part number 72-4-7518 and lot numbers 9P8360 or AK8393 on the implant. The implant was manufactured with UHMWPE raw material more than 5 years old if it has been in use for over 5 years.
Verify the implant's age by checking the lot number and manufacturing date on the implant packaging.
The recall is for implants with UHMWPE raw material over 5 years old. Oxidation could weaken the material over time, but it does not cause immediate serious injury or death in normal use.
Check for part number 72-4-7518 and lot numbers 9P8360 or AK8393. The implant is affected if it was manufactured more than 5 years ago.
The recall does not require immediate action. Check the implant's age and contact Howmedica Osteonics if you have concerns.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0880-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0880-2024 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.
