Howmedica recalls Size 2 rHead Recon Stem Implant non-coated implants due to higher revision rates than other 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 has recalled its Size 2 rHead Recon Stem Implant non-coated orthopedic implants because studies show they have higher revision rates than other similar implants. This means the implants might not work as expected after surgery, potentially requiring additional procedures.
The recall is based on literature reviews showing these implants have higher revision rates compared to other radial head replacement devices. Revision rates refer to how often the implant needs to be removed and replaced after surgery. This could lead to unsatisfactory surgical outcomes and additional procedures.
Patients who received the Size 2 rHead Recon Stem Implant non-coated implant as part of the Stryker rHead Radial Head and Uni-Elbow system are affected. Those with this specific implant are at risk of needing additional surgery.
Check if you have the rHead Recon Stem Implant non-coated, Size 2. This implant was used in the Stryker rHead Radial Head and Uni-Elbow system. The product code is RCN-S260.
Reach out to Howmedica Osteonics Corp. to confirm if you have the recalled implant and get instructions for next steps.
The recall indicates higher revision rates compared to other implants, but it does not state that the implant causes immediate harm or injury. The risk is related to needing additional surgery after the initial procedure.
Contact Howmedica Osteonics Corp. to confirm if you have the recalled implant and get instructions for next steps.
Look for the rHead Recon Stem Implant non-coated, Size 2 with product code RCN-S260 used in the Stryker rHead Radial Head and Uni-Elbow system.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2717-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2717-2018 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.
