Howmedica Osteonics recalls TRIDENTII PSL CLUSTER50D hip implants with possible smooth edge on acetabular shell. This may cause dislocation in high-risk patients. Affected units have specific catalog numbers and lot numbers.
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Howmedica Osteonics recalls certain hip implants (TRIDENTII PSL CLUSTER50D) for potential smooth edges on the acetabular shell. This could increase dislocation risk in patients with high hip dislocation risk. The recall affects specific catalog numbers and lot numbers.
The acetabular shell may have excessive deburring, creating a smooth surface on the edge. This smooth edge could potentially cause the implant to dislocate in patients at high risk of hip dislocation.
Patients with high risk of hip dislocation who received the TRIDENTII PSL CLUSTER50D implant. The recall applies to specific catalog numbers and lot numbers.
Check for catalog number 742-11-50D and lot numbers 14593551, 15432653, or 15432651. The product is indicated for primary and revision hip surgeries in high-risk patients.
Look for catalog number 742-11-50D and lot numbers 14593551, 15432653, or 15432651 on the implant packaging.
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge, which could increase dislocation risk in high-risk patients.
Check the product details on the implant packaging for the catalog number and lot numbers. If they match, contact Howmedica Osteonics for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Howmedica Osteon: A short, human brand name for headings (e.g. "Trsmima") to request your refund or repair — edit it as you like.
Subject: Recall Z-1629-2024 — Howmedica Osteon: A short, human brand name for headings (e.g. "Trsmima") Howmedica Osteon: A short Hello, I own a Howmedica Osteon: A short, human brand name for headings (e.g. "Trsmima") that is covered by recall Z-1629-2024 from Howmedica Osteon: A short, human brand name for headings (e.g. "Trsmima"). 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.