Howmedica recalls rHead Stem Implant 6mm Collar Size 3 due to higher revision rates than other 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 a specific orthopedic implant for radial head replacement because studies show it has a higher revision rate than other similar implants. This means the implant might not work as intended after surgery.
The implant has a higher revision rate than other radial head replacements based on literature. This means it may not function properly after surgery, requiring additional procedures.
Patients who received this implant during surgery are likely affected. Those with the implant are at risk of needing additional surgery if the implant fails.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system. It was sold under the product name 'rHead Stem Implant 6mm Collar, Size 3' with the model code 310-2016.
Look for the product name 'rHead Stem Implant 6mm Collar, Size 3' and model code 310-2016 on your implant.
The recall is due to higher revision rates than other radial head replacements, meaning it may not perform as expected after surgery.
Check your implant for the product name and model code. If you have the recalled item, contact Howmedica for further instructions.
The implant has a higher revision rate than other similar implants, which may require additional surgery. However, it is not considered immediately dangerous.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2683-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2683-2018 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.
