Zimmer Biomet recalls ACE Trochanteric Nail System products 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 its ACE Trochanteric Nail System products because clinical analysis showed these devices did not meet performance standards for treating femur fractures. This could lead to improper healing or complications in patients needing hip fracture repairs.
The recall follows a failed clinical analysis where the device did not meet performance standards for treating femur fractures. This could result in improper healing or complications during recovery.
Patients who have received the ACE Trochanteric Nail System for femur fractures are likely affected. Those with recent hip or femur fractures requiring surgical repair are at higher risk.
Check for the product codes 903208000, 903208010, 903208015, 903208020, or 903208025 on the packaging. These are specific models of the ACE Trochanteric Nail System.
Look for the model numbers 903208000, 903208010, 903208015, 903208020, or 903208025 on the device packaging.
Zimmer Biomet is recalling the ACE Trochanteric Nail System after clinical analysis showed the device did not meet performance standards for treating femur fractures.
The affected models are 903208000, 903208010, 903208015, 903208020, and 903208025.
The recall does not specify a stop-use instruction; the remedy is null, so users should check product codes and contact Zimmer Biomet for further guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1226-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1226-2018 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.
