Howmedica recalls plasma-coated size 2 radial head implants due to higher revision rates than other devices. This may lead to complications 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.
Howmed: Howmedica recalls their plasma-coated size 2 radial head implants because studies show these implants have higher revision rates than other similar devices. This means the implants might not work as expected after surgery.
The implant has a higher revision rate than other radial head replacements. Revision rate refers to how often the implant needs to be replaced after surgery. This may mean the implant doesn't perform as expected post-surgery.
Patients who received this specific implant during surgery are affected. Those with the implant are at risk of needing additional surgery.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system. It was sold with the model number 310-2011.
If you had this implant during surgery, contact your surgeon to confirm if you have the recalled model.
The recall states the implant has a higher revision rate than other devices, but it does not indicate immediate danger to users.
The recall does not require stopping use; it is for patients who had the implant during surgery.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system with model number 310-2011.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2678-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2678-2018 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.
