Howmedica recalls plasma-coated size 4 rHead stem implants for higher revision rates post-surgery. This orthopedic implant may not perform as expected after replacement of the radius proximal end.
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 Osteonics Corp. recalls plasma-coated size 4 rHead stem implants for potential higher revision rates after surgery. This implant may not function as intended following radius replacement procedures.
The implant has a higher revision rate than other similar devices based on literature review. This means patients may need additional surgery more often than expected after the initial procedure.
Patients who received this specific implant during surgery for radius replacement are affected. Those with the implant are at risk of needing additional surgery.
Look for the product name 'rHead Stem Implant Plasma Coated, Size 4' in the Stryker rHead Radial Head and Uni-Elbow system. The recall was issued in 2013 (310-2013).
Your surgeon can confirm if you have the recalled implant and provide next steps.
The recall states the implant has a higher revision rate than other devices, but it does not indicate immediate danger or injury risk.
The recall does not specify a stop-use instruction; patients should contact their surgeon for guidance.
Look for the product name 'rHead Stem Implant Plasma Coated, Size 4' in the Stryker rHead Radial Head and Uni-Elbow system, and check the recall date (2013).
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2680-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2680-2018 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.
