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 after clinical analysis failed to meet performance criteria. This could impact the safety and effectiveness of treating femur fractures.
The device failed clinical analysis for survivorship, meaning the implants may not hold properly over time. This could lead to complications like implant failure or the need for additional surgery.
Patients who received the recalled ACE Trochanteric Nail System for femur fracture treatment are likely affected. Surgeons and medical facilities using these implants during procedures are at risk.
Check for the model numbers 903213125, 903213130, or 903213135 on the product packaging. These are the specific ACE Trochanteric Nail System models recalled by Zimmer Biomet.
Identify the model number on the product packaging to determine if it is one of the recalled models (903213125, 903213130, or 903213135).
Zimmer Biomet is recalling these models after a Device Performance Review failed clinical analysis for survivorship, meaning the implants may not hold properly over time.
The recall record does not specify a remedy, so no action is required beyond checking if your model is listed.
The recall indicates potential implant failure, which could lead to complications like additional surgery, but the record does not specify the exact risk level.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1231-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1231-2018 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.
