Howmedica recalls radial stem implant #3 (Sterile packed) due to higher revision rates than other proximal 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.
Howmed: Howmedica Osteonics Corp. recalls radial stem implant #3 (Sterile packed) for orthopedic use. The implant has a higher revision rate than other similar products, meaning it may not function properly after surgery.
The implant has a higher revision rate than other products in the same surgical area. Revision rate refers to how often the implant needs to be replaced after surgery. This means the implant may not perform as expected post-surgery.
Patients who received the radial stem implant #3 (Sterile packed) for proximal radius replacement are affected. Those who had surgery using this specific implant are most at risk.
Check for the product name 'radial stem implant #3 (Sterile packed)' in the Stryker rHead Radial Head and Uni-Elbow system. The model code is RHA-S3.
Identify if your implant is labeled 'radial stem implant #3 (Sterile packed)' with model RHA-S3 in the Stryker rHead Radial Head and Uni-Elbow system.
The recall is due to higher revision rates compared to other proximal radial head replacement devices, meaning it may not perform as expected after surgery.
The model number is RHA-S3.
No, the recall does not require stopping use; it is a higher revision risk that may need follow-up care.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2729-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2729-2018 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.
