Howmedica recalls rHead Radial Implant : Literature shows higher revision rates than other radial head replacements. Product may not perform as expected 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 is recalling a specific orthopedic implant (rHead Radial Implant 6 mm Collar, Size 4) because studies show it has higher revision rates than other similar implants. This means the implant might not work as intended after surgery.
The implant has been found in studies to have higher revision rates than other radial head replacements. Revision means the implant needs to be removed and replaced, which can cause additional surgery and recovery time.
Patients who received this specific implant during surgery are likely affected. Surgeons and patients using the implant are at risk of needing additional surgery.
Check if your implant is labeled 'rHead, Radial Implant 6 mm Collar, Size 4' or part of the RHA-S460 system. This implant was used in surgeries for replacing the radius bone near the elbow.
Look for the model 'rHead, Radial Implant 6 mm Collar, Size 4' or RHA-S460 on your implant or surgical records.
Studies show this implant has higher revision rates than other radial head replacements, meaning it may not perform as expected after surgery.
The recall does not require immediate action. Check your implant details to see if it matches the recalled model.
The recall indicates a higher risk of needing additional surgery, but it is not immediately dangerous. The hazard is related to long-term performance after surgery.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2732-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2732-2018 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.
