Howmedica Osteonics recalls bipolar stem implants for radius replacement due to higher revision rates than other devices. 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 Osteonics is recalling bipolar stem implants used in radius replacements because they have a higher revision rate than other similar implants. This means the implants might not work as expected after surgery, potentially requiring additional procedures.
The implant has a higher revision rate than other devices based on literature review. This means it may not perform as intended after surgery, leading to complications that could require additional procedures.
Patients who received the recalled bipolar stem implant for radius replacement surgery are affected. Those with the implant are most at risk of needing additional surgery.
The product is part of the Stryker rHead Radial Head and Uni-Elbow system. Look for the model RCN-S1 on the implant packaging.
Look for the model RCN-S1 on the implant packaging to confirm if it's recalled.
The recall is due to higher revision rates than other similar implants, meaning it may not perform as expected after surgery.
Check the implant packaging for the model RCN-S1. If you have the recalled implant, contact Howmedica Osteonics for further instructions.
The recall is based on higher revision rates, not immediate injury risks. The hazard is related to potential need for additional surgery after the implant.
We’ve drafted a message you can send Howmedica Osteon: A short, human brand name for headings (e.g. to request your refund or repair — edit it as you like.
Subject: Recall Z-2714-2018 — Howmedica Osteon: A short, human brand name for headings (e.g. Howmedica Osteon: A short, human bra Hello, I own a Howmedica Osteon: A short, human brand name for headings (e.g. that is covered by recall Z-2714-2018 from Howmedica Osteon: A short, human brand name for headings (e.g.. 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.
