Howmedica recalls Size 4 rHead Recon Stem Implant non-coated implants due to higher revision rates than other radial head replacements. Patients may need additional 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.
Howmed: Howmedica recalls their Size 4 rHead Recon Stem Implant non-coated implants because they have a higher revision rate than other similar implants. This means patients might need additional surgery after the implant.
The implant has a higher revision rate than other radial head replacement devices based on literature review. This means it may not perform as expected after surgery, potentially requiring additional procedures.
Patients who received the Size 4 rHead Recon Stem Implant non-coated implant for radial head replacement are affected. Those with the implant are most at risk of needing additional surgery.
Check for the rHead Recon Stem Implant non-coated, Size 4. The product is part of the Stryker rHead Radial Head and Uni-Elbow system with model RCN-S460.
Reach out to your surgeon to discuss whether the implant needs to be replaced due to higher revision rates.
The recall states the implant has a higher revision rate than other radial head replacements, but it does not indicate immediate danger to users.
The recall does not state that users should stop using the implant; it focuses on potential need for additional surgery.
The model number is RCN-S460.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2721-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2721-2018 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.
