Zimmer Biomet recalls ACE Trochanteric Nail System models due to failed clinical analysis in device performance reviews, potentially affecting fracture treatment outcomes.
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
Zimmer Biomet is recalling specific ACE Trochanteric Nail System models because clinical tests showed they don't meet performance standards for treating femur fractures. This could lead to improper healing or complications for patients using these implants.
The device failed clinical analysis for survivorship, meaning it may not work as intended for healing fractures. This could result in improper bone healing or complications requiring additional surgery.
Patients who received the recalled ACE Trochanteric Nail System for femur fracture treatment are affected. Surgeons and medical staff who used these implants during procedures are also at risk.
Check for model numbers 903211140, 903211225, 903211230, or 903211235 on the product packaging. The system is used for treating femur fractures and includes specific nail sizes and angles.
Identify the model number on the product packaging to confirm if it's in the recalled list.
The device failed clinical analysis for survivorship, meaning it may not meet performance standards for treating femur fractures.
The recall record does not specify a remedy, so contact Zimmer Biomet directly for guidance.
Yes, model numbers 903211140, 903211225, 903211230, and 903211235 are affected.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1230-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1230-2018 from Zimmer Biomet. 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.
