Howmedica Osteonics recalls Radial Head Assy Size 2 implants due to higher revision rates than other proximal radial head replacements. This may lead to less effective surgery outcomes.
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 is recalling Radial Head Assy Size 2 implants used in certain orthopedic surgeries. The recall is because these implants have a higher revision rate than other similar implants, meaning they might not work as well after surgery.
The implant has a higher revision rate than other similar implants, meaning it may not perform as expected after surgery. Revision rates refer to how often the implant needs to be replaced or corrected after the initial surgery.
Patients who received this specific implant during surgery are likely affected. Surgeons and medical staff who used this implant in procedures are at higher risk.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system. It has the model number 410-0004. The product was used for replacing the proximal end of the radius in orthopedic procedures.
Look for the model number 410-0004 on the implant or documentation.
The recall is because this implant has a higher revision rate than other similar implants, meaning it may not perform as expected after surgery.
The recall does not specify a remedy, so there is no action required for the implant itself. Check with your surgeon for guidance.
The recall indicates a higher revision rate, but it does not state that the implant causes injury or serious harm in normal use.
We’ve drafted a message you can send Howmedica Osteon: Radial Head to request your refund or repair — edit it as you like.
Subject: Recall Z-2697-2018 — Howmedica Osteon: Radial Head Howmedica Osteon: Radial Head Hello, I own a Howmedica Osteon: Radial Head that is covered by recall Z-2697-2018 from Howmedica Osteon: Radial Head. 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.
