Howmedica recalls Lateral Assembly, Radial Head Implant Size 2 due to higher revision rates than other implants. This 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 some hand surgeries because studies show it has a higher chance of needing revision surgery compared to other 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 similar implants. Revision means the implant may need to be removed and replaced after surgery, which can happen more often with this product.
Patients who received this implant during surgery are likely affected. Those with the specific implant model are at risk of needing additional surgery.
Check if you received the Lateral Assembly, Radial as a Size 2 implant in the Stryker rHead Radial Head and Uni-Elbow system. The product code is 310-0008.
Look for the product code 310-0008 on the implant or packaging.
The recall states this implant has a higher revision rate than other implants, but it does not indicate immediate danger to users.
The recall does not require stopping use; it is about potential need for revision surgery after the implant is placed.
Check for the product code 310-0008 on the implant or packaging.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2671-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2671-2018 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.
