Howmedica recalls rHead Stem Implant 6mm Collar Size 1 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. The recall is because studies show this implant has a higher revision rate than other similar implants, meaning it might not work well after surgery.
This implant has a higher revision rate than other radial head replacements. Revision rate means the implant may need to be replaced after surgery. The implant might not perform as expected after surgery.
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.
The product is the rHead Stem Implant 6mm Coll: Size 1. It was sold under the Stryker rHead Radial Head and Uni-Elbow system. The recall number is 310-2014.
If you received this implant during surgery, contact your surgeon to confirm if you are affected.
The recall is because studies show this implant has a higher revision rate than other radial head replacements, meaning it might not work well after surgery.
No, this is a surgical implant. You do not need to stop using it; the recall is for patients who received it during surgery to check if they need additional surgery.
Check with your surgeon if you received the rHead Stem Implant 6mm Collar, Size 1 under the Stryker rHead Radial Head and Uni-Elbow system.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2681-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2681-2018 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.
