Howmedica Osteonics recalls TRIDENTII HEMI CLUSTER6:6H hip implants for potential smooth acetabular shell edges that could cause dislocation in high-risk patients. Affected units have specific catalog and lot numbers.
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER66H hip implants for high-risk patients. The acetabular shell may have a smooth edge that increases dislocation risk during surgery.
The acetabular shell may have excessive deburring, creating a smooth surface on the edge. This smooth edge could lead to improper hip joint alignment during surgery, increasing dislocation risk in high-risk patients.
Patients with high risk of hip dislocation who received this specific implant model. Those with the catalog number 702-11-66H or lot number 15445252 are most at risk.
Check for the catalog number 702-11-66H or lot number 15445252 on the implant packaging. This model is indicated for primary and revision hip surgeries in high-risk patients.
Look for the catalog number 702-11-66H or lot number 15445252 on the implant packaging.
This implant is indicated for high-risk hip patients, but the recall addresses a potential smooth edge that could increase dislocation risk during surgery.
Check the implant packaging for the catalog number 702-11-66H or lot number 15445252. If you have these details, contact Howmedica Osteonics for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-1627-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-1627-2024 from Howmedica Osteonics. 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.
