Howmedica recalls radial head implant #3 (Sterile packed) due to higher revision rates than other implants. This orthopedic device 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 its radial head implant #3 (Sterile packed) because studies show it has a higher revision rate than other similar implants. This means the implant might not work as intended after surgery, potentially requiring additional procedures.
The implant has a higher revision rate than other radial head replacements based on literature review. This means it may not function properly after surgery, leading to the need for additional procedures.
Patients who received this implant during surgery are likely affected. Those with the implant are at risk of needing additional surgery if the implant fails.
Check for the product name 'radial head implant #3 (Sterile packed)' in the Stryker rHead Radial Head and Uni-Elbow system. The model number is RHA-H3.
Identify if you have the radial head implant #3 (Sterile packed) with model number RHA-H3 from the Stryker rHead Radial Head and Uni-Elbow system.
The recall is due to higher revision rates compared to other radial head replacement implants, meaning it may not perform as expected after surgery.
Check if you have the radial head implant #3 (Sterile packed) with model number RHA-H3 from the Stryker rHead Radial Head and Uni-Elbow system. Contact Howmedica for further instructions.
The recall indicates a higher revision rate, but the official notice does not specify a risk of serious injury or death.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2723-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2723-2018 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.