Howmedica Osteonics recalls Lateral Assembly, Radial Stem Implant Size 4 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 Osteonics is recalling Lateral Assembly, Radial Stem Implant Size 4 for orthopedic use. This implant has been found to have a higher revision rate than other similar implants, meaning it may not function properly after surgery.
The implant has a higher revision rate than other radial head replacements. Revision rate refers to how often the implant needs to be replaced after surgery. This means the implant may not perform as expected after surgery.
Patients who received this implant during surgery are likely affected. Those with the implant are at risk of needing additional surgery if the implant fails.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system. It was sold under the product code 310-0003.
If you had this implant during surgery, contact your surgeon to confirm if you are affected.
The implant has a higher revision rate than other radial head replacements, meaning it may not perform as expected after surgery.
Contact your surgeon to confirm if you are affected. They will advise on next steps.
The recall does not mention a fix or remedy. You may need additional surgery if the implant fails.
We’ve drafted a message you can send Howmedica Osteon: a short, human brand name for headings (e.g. to request your refund or repair — edit it as you like.
Subject: Recall Z-2666-2018 — Howmedica Osteon: a short, human brand name for headings (e.g. Howmedica Osteon: a short, human bra Hello, I own a Howmedica Osteon: a short, human brand name for headings (e.g. that is covered by recall Z-2666-2018 from Howmedica Osteon: a short, human brand name for headings (e.g.. 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.
