Zimmer Biomet recalls ACE Trochanteric Nail System screws 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 screws after clinical analysis showed they don't meet performance standards for treating femur fractures. This could lead to improper healing or complications for patients using the device.
The device failed clinical analysis for survivorship, meaning the screws may not hold properly in the bone over time. This could cause the screws to loosen or fail, leading to improper fracture healing or the need for additional surgery.
Patients who received the ACE Trochanteric Nail System screws for femur fractures are likely affected. Surgeons and medical facilities using these screws for treatment are at risk of complications.
Check for screws with model numbers 903311060 through 903311130. These screws are used in the ACE Trochanteric Nail System for treating femur fractures.
Reach out to Zimmer Biomet directly for guidance on the recall and next steps.
Zimmer Biomet conducted a device performance review that failed clinical analysis for survivorship, meaning the screws may not hold properly in bone over time.
The screws could loosen or fail, potentially causing improper fracture healing or requiring additional surgery.
Look for model numbers 903311060 through 903311130 on the screws used in the ACE Trochanteric Nail System for femur fractures.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1234-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1234-2018 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.
