Howmedica recalls Lateral Assembly, Radial Head Impl Assembly, Size 2 orthopedic implants due to higher revision rates than other radial head replacements. 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.
Howmedica is recalling a specific orthopedic implant (Lateral Assembly, Radial: Size 2) because studies show it has a higher revision rate than other similar implants. This means the implant might not work as expected after surgery, potentially requiring additional procedures.
The implant has been found to have a higher revision rate compared to other radial head replacements. Revision rate refers to how often the implant needs to be replaced after surgery. This could mean the implant doesn't perform as expected post-surgery.
Patients who received this specific orthopedic implant for radius replacement surgery are likely affected. Those with the implant are at risk of needing additional surgery if the implant fails.
Check if you have the Lateral Assembly, Radial Head Impl Assembly, Size 2 part number 310-00011 used in the Stryker rHead Radial Head and Uni-Elbow system. This implant is for replacing the proximal end of the radius.
Verify if your implant matches the description: Lateral Assembly, Radial Head Impl Assembly, Size 2 with part number 310-00011 for the Stryker rHead Radial Head and Uni-Elbow system.
The recall is due to higher revision rates compared to other radial head replacements, meaning the implant may not perform as expected after surgery.
You should check if your implant matches the description and contact Howmedica if you are unsure.
The recall indicates a higher revision rate, but it does not mean the implant causes immediate harm. It may require additional surgery if it fails.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2674-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2674-2018 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.
