Howmedica recalls rHead Radial Implant : Higher revision rates than other radial head replacements may lead to less effective surgery outcomes.
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 due to higher revision rates compared to other devices. This means the implant might not work as well after surgery, potentially requiring additional procedures.
The implant has been found to have higher revision rates than other similar devices based on medical literature. Revision rates refer to how often the implant needs to be replaced after surgery. This could mean the implant doesn't perform as expected post-surgery.
Patients who received this specific implant during surgery are likely affected. Those with the rHead Radial Implant 6 mm Collar, Size 3 are at risk of needing additional surgery.
Check if your implant is labeled 'rHead, Radial Implant 6 mm Collar, Size 3' or part of the RHA-S360 system. This product was used in surgeries for replacing the proximal end of the radius.
Review your surgical records or implant documentation to confirm if you have the rHead Radial Implant 6 mm Collar, Size 3.
The recall is due to higher revision rates compared to other radial head replacement devices, which may lead to less effective surgery outcomes.
The implant is not immediately dangerous but may require additional surgery if it doesn't perform as expected after the initial procedure.
Look for the label 'rHead, Radial Implant 6 mm Collar, Size 3' or the RHA-S360 system in your surgical records.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2730-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2730-2018 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.
