Howmedica recalls radial head implant #4 (Sterile packed) due to higher revision rates than other implants. This orthopedic device 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.
Howmed: Howmedica Osteonics Corp. recalls radial head implant #4 (Sterile packed) for orthopedic use. The device has been identified as having a higher revision rate than other similar implants, meaning it may not function properly after surgery.
This implant has been found to have a higher revision rate than other similar implants. Revision means the implant needs to be replaced after surgery, which can happen due to the implant not performing as expected post-surgery.
Patients who received this radial head implant during surgery are likely affected. Those with the implant are at risk of needing additional surgery if the device fails.
Check for the product name 'radial head implant #4 (Sterile packed)' or the model code 'RHA-H4'. This implant is part of the Stryker rHead Radial Head and Uni-Elbow system.
Look for the product name 'radial head implant #4 (Sterile packed)' or model code 'RHA-H4' on the implant or documentation.
The recall is due to higher revision rates than other similar implants, meaning it may not perform as expected after surgery.
The official recall does not mention any remedy or fix for this implant.
The official recall does not specify who to contact for assistance.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2724-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2724-2018 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.
