Zimmer Biomet recalls ACE Trochanteric Nail System devices 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 ACE Trochanteric Nail System devices after clinical analysis failed to meet performance standards. This could impact the safety and effectiveness of treating femur fractures.
The recall follows a failed clinical analysis in device performance reviews, meaning the nails may not function as intended for fracture treatment. This could lead to complications in healing or treatment outcomes.
Patients who received the ACE Trochanteric Nail System for femur fracture treatment are likely affected. Surgeons and medical facilities using these devices for orthopedic procedures are at risk.
The recalled devices include specific model numbers: 903213140, 903213225, 903213230, and 903213235. These are used for treating femur fractures in orthopedic procedures.
Identify the model number on the device packaging or label to confirm if it is one of the recalled numbers.
Zimmer Biomet is recalling the ACE Trochanteric Nail System after clinical analysis failed to meet performance standards in device performance reviews.
The recall indicates potential issues with the device's performance, which could affect fracture treatment outcomes, but specific injury risks are not detailed in the notice.
Check the device model number on the packaging or label; recalled models include 903213140, 903213225, 903213230, and 903213235.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1232-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1232-2018 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.
