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. is recalling radial stem implant #2 (Sterile packed) because studies show it has a higher revision rate than other similar implants. This means the implant might not work as intended after surgery, potentially requiring additional procedures.
The implant has been found to have a higher revision rate than other similar implants based on literature review. This means it may not perform as expected after surgery, potentially requiring additional procedures.
Patients who received this radial stem implant for proximal radius replacement are affected. Those with the implant are at risk of needing additional surgery if the implant fails.
This product is labeled as 'radial stem implant #2 (Sterile packed)' and is part of the Stryker rHead Radial Head and Uni-Elbow system. The model number is RHA-S260.
Look for the product name 'radial stem implant #2 (Sterile packed)' and model number RHA-S260 on the implant packaging or documentation.
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 record does not mention any remedy or fix for this implant.
The recall record 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-2728-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2728-2018 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.
