Howmedica recalls radial stem implant #1 (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 #1 (Sterile packed) for orthopedic use. The implant has been found to have higher revision rates than other similar devices, meaning it might not function properly after surgery.
The implant has a higher revision rate than other similar devices based on literature review. This means it may not perform as expected after surgery, potentially requiring additional procedures.
Patients who received this implant during surgery are likely affected. Those with the implant in their radius are at risk of needing additional surgery.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system. It is identified by the model RHA-S1.
Look for the model number RHA-S1 on the implant packaging or documentation.
The recall states the implant has a higher revision rate than other similar devices, but it does not indicate immediate danger to users.
The recall does not require stopping use; it is a higher revision risk that may require additional surgery.
This implant is part of the Stryker rHead Radial Head and Uni-Elbow system with model number RHA-S1.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2725-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2725-2018 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.