Howmedica recalls rHead Recon Stem Implant 6mm Collar Size 4 due to higher revision rates than other radial head replacements. This implant 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 for replacing the radius bone. The recall is because studies show this implant has a higher chance of needing revision surgery compared to other similar implants.
The implant has a higher revision rate than other similar implants based on literature reviews. This means it may not function as intended after surgery, requiring additional procedures.
Patients who received this implant during surgery are likely affected. Those with the implant are at risk of needing additional surgery.
The product is the rHead Recon Stem Implant 6mm Collar, Size : 4. It was sold under the Stryker rHead Radial Head and Uni-Elbow system.
Review your surgical records to confirm if you received the rHead Recon Stem Implant 6mm Collar, Size 4.
The recall is because studies show this implant has a higher revision rate than other radial head replacements, meaning it may not perform as expected after surgery.
If you received this implant, check your surgical records to confirm. There is no immediate action required beyond verifying your implant type.
The implant has a higher chance of needing revision surgery compared to other implants, but it is not immediately dangerous in normal use.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2692-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2692-2018 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.