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 because clinical tests showed they don't meet performance standards for treating femur fractures. This could lead to improper healing or complications for patients needing these surgical fixes.
The recall is based on clinical tests failing to show the device meets performance standards for healing fractures. This means the nails might not work as intended, potentially causing improper bone healing or complications.
Patients who received the recalled ACE Trochanteric Nail System for femur fracture treatment are affected. Surgeons and medical facilities using these devices for procedures are also at risk.
Check for the model numbers 903211125, 903211130, or 903211135 on the device packaging or labels. These are the specific ACE Trochanteric Nail System models recalled by Zimmer Biomet.
Look for the model numbers 903211125, 903211130, or 903211135 on the device packaging or labels to confirm if it's recalled.
Zimmer Biomet is recalling these devices because clinical tests failed to show they meet performance standards for treating femur fractures.
The recall record does not specify a remedy, so check with Zimmer Biomet directly for guidance.
The recall indicates potential issues with healing, but specific risks are not detailed in the official notice.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1229-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1229-2018 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.
