Zimmer Biomet recalls ACE Trochanteric Nail System screws due to failed clinical analysis in device performance reviews. This affects surgical implants for femur fractures. Consumers should contact the manufacturer for details.
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 failed to meet performance standards. This could lead to improper healing of femur fractures if used without correction.
The device performance review failed clinical analysis for survivorship, meaning the screws may not hold properly over time. This could cause improper healing of fractures in the femur, leading to complications.
Surgical patients who received the recalled ACE Trochanteric Nail System screws for femur fractures are affected. Patients with the specific screw sizes listed are most at risk.
Check if your surgical implant includes the ACE Trochanteric Nail System screws with sizes 60mm, 65mm, 70mm, 75mm, 80mm, 85mm, 90mm, 95mm, or 100mm. These screws were used in procedures for femur fractures.
Reach out to Zimmer Biomet directly for specific guidance on the recalled product and next steps.
Zimmer Biomet conducted a device performance review that failed clinical analysis for survivorship, meaning the screws may not hold properly over time.
The screws could lead to improper healing of femur fractures if not corrected, as the device performance review failed to meet clinical standards.
Look for screws with sizes 60mm, 65mm, 70mm, 75mm, 80mm, 85mm, 90mm, 95mm, or 100mm used in femur fracture procedures.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1233-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1233-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
