Howmedica recalls radial stem implant #4 (Sterile packed) due to higher revision rates than other proximal radial head replacements. This implant may not perform as expected after surgery.
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 is recalling its radial stem implant #4 (Sterile packed) because studies show it has a higher revision rate than other similar implants. This means the implant might not work properly after surgery, potentially requiring additional procedures.
This implant has been found to have a higher revision rate compared to other proximal radial head replacement devices. Revision rate refers to how often the implant needs to be replaced after surgery. The product may not perform as expected post-surgery, which could lead to additional procedures.
Patients who received the radial stem implant #4 (Sterile packed) for proximal radius replacement are affected. Those who have undergone surgery with this specific implant are most at risk.
Check if your implant is labeled 'RHA-S4' or part of the Stryker rHead Radial Head and Uni-Elbow system. The product is a sterile packed radial stem implant #4 used for proximal radius replacement.
Talk to your surgeon about whether you have the recalled radial stem implant #4 (Sterile packed).
The recall states this implant has a higher revision rate than other similar implants, but it does not indicate immediate danger to users.
Check if your implant is labeled 'RHA-S4' or part of the Stryker rHead Radial Head and Uni-Elbow system.
The recall does not require stopping use; it is about potential need for additional procedures after surgery.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2731-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2731-2018 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.
