Zimmer Biomet recalls ACE Trochanteric Nail Systems 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 Systems after clinical analysis showed they don't meet performance standards. This could lead to improper fracture healing or complications for patients needing hip fracture repairs.
The device failed clinical analysis for survivorship, meaning the nails may not hold properly over time. This could cause improper healing of fractures or require additional surgeries.
Patients with hip fractures or related injuries who received these specific nail systems are likely affected. Those undergoing orthopedic surgery with these devices face the highest risk.
Check for model numbers 903011225, 903011230, 903011235, 903013225, 903013230, or 903013235 on the product packaging or documentation.
Look for model numbers 903011225, 903011230, 903011235, 903013225, 903013230, or 903013235 on the product packaging.
Zimmer Biomet conducted a Device Performance Review that failed clinical analysis for survivorship, meaning the nails may not hold properly over time.
The affected models are 903011225, 903011230, 903011235, 903013225, 903013230, and 903013235.
The recall does not specify a stop-use instruction; patients should consult their surgeon about potential risks.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1225-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1225-2018 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.
