Howmedica Osteonics recalls TRIDENTII PSL CLUSTER52E hip implants for potential smooth edge on acetabular shell. This may 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 PSL CLUSTER5:2E hip implants 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 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 with high hip dislocation risk during movement.
Patients with high risk of hip dislocation who received the TRIDENTII PSL CLUSTER52E implant during surgery. Surgeons and hospitals that used this specific model are most at risk.
Check if your implant has catalog number 742-11-52E or lot numbers 14876552 or 14876553. This model is indicated for primary and revision hip surgeries in high-risk patients.
Identify your implant's catalog number (742-11-52E) and lot numbers (14876552 or 14876553) to confirm if it's affected.
The recall indicates a potential smooth edge on the acetabular shell that could increase dislocation risk in high-risk patients, but the hazard is not confirmed to cause injury.
Check your implant's catalog number and lot numbers to see if it's affected. If it is, contact Howmedica Osteonics for further instructions.
Affected implants have catalog number 742-11-52E and lot numbers 14876552 or 14876553.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-1630-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-1630-2024 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.
