Howmedica recalls Lateral Assembly, Radial Stem Implant Size 3 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 a specific orthopedic implant used in radius replacement surgeries because studies show it has a higher revision rate than other similar implants. This means the implant might not work as intended after surgery.
This implant has been found to have a higher revision rate than other implants for replacing the radius. Revision means the implant needs to be removed and replaced, which can happen after surgery. The implant may not perform as expected after surgery, leading to potential complications.
Patients who received this implant during surgery are likely affected. Surgeons and medical facilities that used this implant for radius replacements are at higher risk.
Check if you have the Lateral Assembly, Radial Stem Implant, Size 3 used in the Stryker rHead Radial Head and Uni-Elbow system. The product code is 310-0002.
Review your surgical records or implant documentation to confirm if you have the recalled Lateral Assembly, Radial Stem Implant, Size 3.
The recall is due to higher revision rates compared to other implants for radius replacements, meaning it may not perform as expected after surgery.
The recall record does not mention a remedy or fix for this implant.
Check if you have the Lateral Assembly, Radial Stem Implant, Size 3 used in the Stryker rHead Radial Head and Uni-Elbow system with product code 310-0002.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2665-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2665-2018 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.