Howmedica Osteonics recalls #2 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.
Howmed: Howmedica Osteonics is recalling its #2 Bipolar stem implant (Sterile packed) due to higher revision rates compared to other radial head replacements. This means the implant might not function as expected after surgery, requiring additional procedures.
The implant has a higher revision rate than other similar devices based on literature review. This means it may not perform as intended after surgery, potentially requiring additional procedures to fix issues.
Patients who received the #2 Bipolar stem implant for radial head replacement surgery are likely affected. Those with the implant in the Stryker rHead Radial Head and Uni-Elbow system are at higher risk.
Check if your implant is labeled as #2 Bipolar stem (Sterile packed) in the Stryker rHead Radial Head and Uni-Elbow system. The product code is RCN-S2.
Look for the product code RCN-S2 on the implant packaging or label.
The recall is due to higher revision rates compared to other devices, but it does not indicate immediate danger to users.
No, the recall does not require stopping use; it is for potential higher revision rates after surgery.
Check if your implant is labeled as #2 Bipolar stem (Sterile packed) in the Stryker rHead Radial Head and Uni-Elbow system with product code RCN-S2.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2716-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2716-2018 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.
