Zimmer Biomet recalls ACE Trochan: A device performance review failed clinical analysis for survivorship, meaning the nail may not hold properly over time.
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 due to a device performance issue that could lead to the nail failing to stay in place over time. This risk affects patients who have had the nail implanted for hip fractures.
The device performance review found the nail may not stay in place long-term, which could lead to the nail failing to hold the bone fragments together. This risk is specific to the medical context of hip fracture treatment.
Patients who received the ACE Trochanteric Nail System for hip fractures are affected. Those with osteoporotic bone or revision procedures are at higher risk.
The recalled product is the ACE Trochanteric Nail System with model STER TROC LAG SCR 70 MM. It was sold under Zimmer Biomet's brand for hip fracture treatments.
Your doctor will determine if the recalled nail is in your treatment and advise on next steps.
The recall is due to a device performance issue that may cause the nail to fail over time, but it does not indicate immediate danger to patients.
The recalled product is the ACE Trochanteric Nail System with model STER TROC LAG SCR 70 MM, used for hip fracture treatments.
Contact your doctor to determine if the recalled product is in your treatment and follow their advice.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1228-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1228-2018 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.
