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 bipolar radial head implants used in certain shoulder surgeries due to higher revision rates compared to other implants. This means the implants might not function properly after surgery, leading to additional procedures.
The implant has a higher revision rate than other similar implants, meaning it may not work as intended after surgery. This could lead to the need for additional surgeries to fix problems with the implant.
Patients who received the bipolar radial head implant for shoulder replacement surgery are likely affected. Those with the Stryker rHead Radial Head and Uni-Elbow system are at higher risk.
Check if you have the bipolar radial head implant for shoulder replacement in the Stryker rHead Radial Head and Uni-Elbow system. The product code is RCN-H2.
Look for the product code RCN-H2 on the implant packaging or documentation.
The recall is due to higher revision rates compared to other proximal radial head replacement devices, meaning the implant may not perform as expected after surgery.
Check the product code RCN-H2 on the implant packaging or documentation to confirm if it's affected. Contact Howmedica Osteonics for further guidance.
The recall is based on higher revision rates, not immediate injury risks. The hazard is that the implant may not function properly after surgery, requiring additional procedures.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2711-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2711-2018 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.
