Howmedica Osteonics recalls TRIDENTII HEMI CLUSTER54E hip implants for potential smooth acetabular shell edges, which may cause dislocation in high-risk patients. Affected units include specific lot numbers from 2023.
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Howmedica Osteonics is recalling a specific hip implant model (TRIDENTII HEMI CLUSTER54E) used for high-risk hip dislocation cases. The recall is due to a possible smooth edge on the acetabular shell that could increase dislocation risk during surgery.
The acetabular shell may have excessive deburring, creating a smooth surface on its edge. This smooth edge could potentially lead to dislocation during hip surgery for patients at high risk of hip dislocation.
Patients with high risk of hip dislocation who received this specific implant model during surgery. Surgeons and medical facilities using the product are also affected.
Check for the product name 'TRIDENTII HEMI CLUSTER54E' on the implant. Affected units include specific lot numbers listed in the recall notice (e.g., 15293151, 15293152, etc.).
Review the implant's lot number to see if it matches the affected numbers listed in the recall (e.g., 15293151, 15293152).
The recall is for specific models used in high-risk hip dislocation cases. If you received this model, contact Howmedica Osteonics for guidance.
Affected lot numbers include 15293151, 15293152, 15293153, 15432251, 15432252, 15432253, 15432254, 15432351, 15432451, and 16265752.
The recall does not require immediate removal; check the lot number to see if it's affected. If it is, contact Howmedica Osteonics for further instructions.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-1625-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-1625-2024 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.
