Howmedica Osteonics recalls Radio Capitellum Size 3 implants due to higher revision rates than other radial head replacements. This may lead to less effective surgery 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.
Howmedica Oste: Radio Capitellum Size 3 implants for radial head replacements have been recalled because studies show they have higher revision rates than other similar implants. This means the implants might not work as well after surgery.
The implant has been found to have higher revision rates than other radial head replacements in studies. Revision rates refer to how often the implant needs to be replaced after surgery. This means the implant might not perform as expected after surgery.
Patients who received this specific implant during surgery are likely affected. Surgeons and medical facilities that used this implant in procedures are at higher risk.
Check if you received the Radio Capitellum, Recon Head, Size #3 implant as part of the Stryker rHead Radial Head and Uni-Elbow system. The product code is 410-0008.
Review your surgical records to confirm if you received the Radio Capitellum, Recon Head, Size #3 implant with product code 410-0008.
The recall is due to higher revision rates compared to other radial head replacements, meaning the implant may not perform as expected after surgery.
The recall record does not mention any remedy or fix for this implant.
Check your surgical records for the Radio Capitellum, Recon Head, Size #3 implant with product code 410-0008 as part of the Stryker rHead Radial Head and Uni-Elbow system.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-2701-2018 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-2701-2018 from Howmedica Osteonics. 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.
