Howmedica Osteonics recalls a specific orthopedic implant for higher revision rates post-surgery. Learn if you have the affected model and what to do.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Howmedica Osteonics recalls a right Radio Capitellum Large implant used in certain shoulder surgeries due to higher revision rates than other implants. This means the implant may not function as expected after surgery, potentially requiring additional procedures.
The implant has a higher revision rate than other similar implants, meaning it may not work properly after surgery. This could lead to needing another surgery to fix the problem.
Patients who received this specific implant during surgery are likely affected. Those with the implant in their shoulder are most at risk.
Check if you have the Radio Capitellum Large, Right implant with model number 410-0002 used in the Stryker rHead Radial Head and Uni-Elbow system.
Look for the model number 410-0002 on the implant or documentation.
The recall is due to higher revision rates than other implants, but it does not cause immediate harm. The implant may need reoperation.
No immediate action is needed. The recall is for potential future revision needs, not an immediate hazard.
Check for model number 410-0002 in the Stryker rHead Radial Head and Uni-Elbow system.
We’ve drafted a message you can send Howmedica Osteon: a short, human brand name for headings (e.g. "Trsmima") to request your refund or repair — edit it as you like.
Subject: Recall Z-2695-2018 — Howmedica Osteon: a short, human brand name for headings (e.g. "Trsmima") Howmedica Osteon: a short Hello, I own a Howmedica Osteon: a short, human brand name for headings (e.g. "Trsmima") that is covered by recall Z-2695-2018 from Howmedica Osteon: a short, human brand name for headings (e.g. "Trsmima"). 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.
