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 may not perform as expected after surgery, leading to higher revision rates. This means patients might need additional surgeries to fix issues with the implant.
Patients who received this specific orthopedic implant during surgery are likely affected. Those with the implant in their shoulder 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-H3 model number.
Reach out to your surgeon to discuss whether you have the recalled implant.
The recall is due to higher revision rates compared to other implants, meaning the product may not perform as expected after surgery.
No, the recall does not require stopping use; it involves discussing with your surgeon about potential revision.
Contact your surgeon to determine if you need additional surgery due to the implant's potential performance issues.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2712-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2712-2018 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.
