Howmedica recalls Radio Capitell: Higher revision rates than other radial head replacements may lead to implant failure post-surgery. Affected units include specific model numbers from Stryker rHead Radial Head system.
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 a specific orthopedic implant (Radio Capitellum Broach Large, Right) due to higher revision rates compared to other similar implants. This means the implant may not function as intended after surgery, potentially requiring additional procedures.
The implant has been found to have higher revision rates than other similar implants based on literature reviews. Revision rates refer to how often the implant needs to be removed and replaced after surgery. This could mean the implant may not perform as expected after surgery.
Orthopedic patients who received this specific implant during surgery with the Stryker rHead Radial Head system are affected. Patients who have had the implant replaced in the past are at higher risk.
Check if your implant is labeled 'Radio Capitellum Broach Large, Right' and part of the Stryker rHead Radial Head system. The specific model number for this recall is 410-0303.
Review your implant label for the model number 410-0303 and the product name 'Radio Capitellum Broach Large, Right'.
The recall indicates higher revision rates than other similar implants, meaning it may not perform as expected after surgery. However, this does not mean it causes immediate harm.
No immediate action is required. The recall is for patients who had this specific implant during surgery; they should check their implant details and contact their surgeon.
Check your implant label for the model number 410-0303 and the product name 'Radio Capitellum Broach Large, Right'. Contact your surgeon for further guidance.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2710-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2710-2018 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.
