Howmedica recalls radial stem implant #2 (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 #2 (Sterile packed) for orthopedic use. The recall is due to higher revision rates compared to other similar implants, meaning the device may not function properly after surgery.
The implant has a higher revision rate than other similar devices based on literature reviews. This means it may not perform as expected after surgery, potentially requiring additional procedures.
Patients who received this radial stem 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 stem implant #2 (Sterile packed)' in the Stryker rHead Radial Head and Uni-Elbow system. The model code is RHA-S2.
Look for the product name 'radial stem implant #2 (Sterile packed)' in the Stryker rHead Radial Head and Uni-Elbow system with model code RHA-S2.
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 recall does not include a specific remedy, so check with your surgeon about potential next steps.
The implant has a higher revision rate than other similar devices, but the recall indicates a low risk of serious injury.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2727-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2727-2018 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.
