Howmedica recalls Radial Head Assy Size #3 implants due to higher revision rates than other proximal radial head replacements. This may lead to unsatisfactory surgical 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.
Howmed: Howmedica is recalling Radial Head Assy Size #3 implants because they have a higher revision rate than other similar implants. This means the implants might not work as expected after surgery, potentially requiring additional procedures.
The implant has a higher revision rate than other similar implants, meaning it may not perform as expected after surgery. This could lead to the need for additional procedures to correct the issue.
Patients who received this specific implant during surgery are likely affected. Those with the implant are at risk of needing additional surgery if the implant fails.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system. It has the model number 410-0005.
Look for the model number 410-00:00 on the implant or documentation.
The recall states the implant has a higher revision rate than other similar implants, but it does not indicate immediate danger or injury.
The recall does not specify a need to stop using the implant; it focuses on potential revision rates after surgery.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system with model number 410-0005.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2698-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2698-2018 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.
