Howmedica recalls Radial Head Assy Size #4 implants due to higher revision rates than other proximal radial head replacements. Product 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 radial head implant used in shoulder 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 the procedure.
This implant has been found to have a higher revision rate than other similar implants based on medical literature. Revision means the implant needs to be removed and replaced, which can happen after surgery due to the implant not performing as expected.
Patients who received this specific radial head implant during surgery are likely affected. Surgeons and medical facilities that used this implant for shoulder replacements are at higher risk.
Check if you have the Radial Head Assy Size #4 implant with model number 410-0006 used in the Stryker rHead Radial Head and Uni-Elbow system. This implant is for replacing the proximal end of the radius in shoulder surgeries.
Identify if your implant matches the description: Radial Head Assy Size #4 with model number 410- 0006 in the Stryker rHead system.
The recall is due to higher revision rates compared to other proximal radial head replacements, meaning the implant may not perform as expected after surgery.
The implant is not dangerous in normal use but has a higher chance of needing revision surgery compared to other implants.
Check if your implant matches the description and contact Howmedica for further guidance.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2699-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2699-2018 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.