Howmedica Osteonics recalls bipolar radial head implants for potential higher revision rates post-surgery. This orthopedic implant may not perform as expected after replacement.
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 Osteonics has recalled certain bipolar radial head implants due to higher revision rates compared to other similar implants. This means the implants might not function properly after surgery, potentially requiring additional procedures.
The implant has a higher revision rate than other similar implants based on literature reviews. This means it may not perform as expected after surgery, leading to the need for additional procedures.
Patients who received this specific implant during surgery are likely affected. Those with the implant in their radius are at risk of needing additional surgery.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system. It was sold under the RCN-H4 model number.
If you had this implant during surgery, contact your surgeon to confirm if it's part of the recall.
The recall indicates a higher revision rate than other implants, meaning it may not perform as expected after surgery, but it does not indicate immediate danger.
No, this is a surgical implant. The recall does not require stopping use; it's about potential need for additional procedures if the implant fails.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system with model RCN-H4. Contact your surgeon to confirm.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2713-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2713-2018 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.
