Howmedica Osteonics recalls #4 Bipolar stem implants for potential higher revision rates post-surgery. Learn if your implant is affected and what to do.
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.
Howmedica Osteonics is recalling a specific type of orthopedic implant for the radius bone. This implant may not perform as expected after surgery, leading to a higher chance of needing additional surgery.
The implant may not function properly after surgery, increasing the chance of needing another procedure. This is based on literature reviews comparing it to other similar implants.
Patients who received this implant during surgery for the radius bone are affected. Those with the specific implant model (RCN-S4) are most at risk.
Check if your implant is labeled as #4 Bipolar stem implant (Sterile packed) with model RCN-S4. This implant was used in the Stryker rHead Radial Head and Uni-Elbow system.
Look for the model number RCN-S4 on your implant packaging or surgical records.
The recall states the implant may not perform as expected after surgery, leading to a higher revision rate compared to other implants. It is not immediately dangerous but may require additional surgery.
No, this is a surgical implant. The recall does not require stopping use but may indicate a need for additional surgery if issues arise.
Check for the model number RCN-S4 on your implant packaging or surgical records. This implant was used in the Stryker rHead Radial Head and Uni-Elbow system.
We’ve drafted a message you can send Howmedica Osteon: 1-2 words to request your refund or repair — edit it as you like.
Subject: Recall Z-2720-2018 — Howmedica Osteon: 1-2 words Howmedica Osteon: 1-2 words Hello, I own a Howmedica Osteon: 1-2 words that is covered by recall Z-2720-2018 from Howmedica Osteon: 1-2 words. 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.
