Howmedica recalls Lateral Assembly, Radial Implant Size 1 orthopedic implants due to higher revision rates than other radial head replacements. This may affect post-surgery performance.
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 Lateral Assembly, Radial Implant, Size 1 orthopedic implants for replacement of the radius proximal end. The recall is because these implants have a higher revision rate than other similar implants, meaning they might not work as expected after surgery.
The implant has a higher revision rate than other similar implants, meaning it may not function properly after surgery. Revision rate refers to how often the implant needs to be replaced due to failure.
Patients who received this specific orthopedic implant during surgery are likely affected. Those with the implant are at risk of needing additional surgery if the implant fails.
Check if you received the Lateral Assembly, Radial Implant, Size 1 orthopedic implant for radius replacement in the Stryker rHead Radial Head and Uni-Elbow system. The product code is 310-0000.
Your surgeon can confirm if you have the recalled implant and advise on next steps.
The recall is because these implants have a higher revision rate than other similar implants, meaning they may not perform as expected after surgery.
No, this is a surgical implant. The recall does not require stopping use but may require additional surgery if the implant fails.
Check if you received the Lateral Assembly, Radial Implant, Size 1 orthopedic implant for radius replacement in the Stryker rHead Radial Head and Uni-Elbow system with product code 310-0000.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2663-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2663-2018 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.
