Howmedica recalls rHead Standard Extended Stem implants due to higher revision rates than other radial head replacements. This may lead to complications 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 used in radius joint replacements because studies show it has a higher revision rate than other similar implants. This means the implant might not work as expected after surgery, potentially requiring additional procedures.
The implant has a higher revision rate than other similar implants based on literature reviews. Revision means the implant needs to be removed and replaced, which can cause complications after surgery.
Patients who received this specific implant during surgery are likely affected. Those with the implant in their radius joint are at risk of needing additional surgery.
Check if you have the rHead Standard Extended Stem, 6mm Collar, Size 2 implant. This is part of the Stryker rHead Radial Head and Uni-Elbow system, with part number 410-0101.
Identify if your implant matches the rHead Standard Extended Stem, 6mm Collar, Size 2 with part number 410-0101.
The recall is due to higher revision rates than other similar implants, which may lead to complications after surgery.
The recall does not require immediate action, but you should check with your surgeon about potential revision needs.
The implant has a higher revision rate than other similar implants, but it is not considered immediately dangerous.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2704-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2704-2018 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.
