Howmedica recalls Lateral Assembly, Radial Stem Implant Size 2 due to higher revision rates than other radial head replacements. This implant may not perform as expected post-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 some hand surgeries because studies show it has a higher chance of needing revision after surgery compared to other implants. This means the implant might not work as intended following the procedure.
This implant is designed to replace the top part of the radius bone in the hand. Studies show it has a higher revision rate than other implants, meaning it may not function properly after surgery and could require additional procedures.
Patients who received this implant during surgery are likely affected. Those with the implant in their hand are at risk for needing additional surgery.
Check if you have the Lateral Assembly, Radial Stem Implant, Size : 310-0001. This implant is used in the Stryker rHead Radial Head and Uni-Elbow system for hand replacements.
Your surgeon can confirm if you have the recalled implant and advise on next steps.
The recall states the implant has a higher revision rate than other implants, but it is not considered immediately dangerous. It may require additional surgery if it doesn't perform as expected.
Check if you have the Lateral Assembly, Radial Stem Implant, Size 2 with part number 310-0001 used in the Stryker rHead Radial Head and Uni-Elbow system.
No, the recall does not require stopping use. Patients should contact their surgeon to determine if additional surgery is needed.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2664-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2664-2018 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.
