Howmedica recalls rHead Recon Stem Implant Plasma Coated Size 1 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 its rHead Recon Stem Implant Plasma Coated, Size 1 for orthopedic use. The recall is because studies show this implant has a higher revision rate compared to other similar implants, meaning it might not work as intended after surgery.
This implant has been found to have a higher revision rate than other radial head replacements in studies. Revision rate refers to how often the implant needs to be replaced after surgery. If the implant doesn't perform as expected, patients may need additional surgery.
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.
Check if you received the rHead Recon Stem Implant Plasma Coated, Size 1. This implant is used in the Stryker rHead Radial Head and Uni-Elbow system. The recall number is 310-2018.
Your surgeon can confirm if you received the recalled implant and provide guidance on next steps.
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.
No, this is a surgical implant. The recall does not require stopping use but may require additional surgery if the implant fails.
Check if you received the rHead Recon Stem Implant Plasma Coated, Size 1 in the Stryker rHead Radial Head and Uni-Elbow system. The recall number is 310-2018.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2685-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2685-2018 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.
