Zimmer Biomet recalls ACE Trochanteric Nail System models 125, 130, and 135 degrees for potential device performance failure in clinical analysis, requiring medical review.
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 three specific ACE Trochanteric Nail System models due to a device performance issue that failed clinical analysis. This could affect surgical outcomes for hip fractures and requires medical evaluation.
The device failed clinical analysis for survivorship, meaning the nails may not hold properly over time. This could lead to complications like implant failure or the need for additional surgery.
Patients who received the recalled ACE Trochanteric Nail System during surgery are likely affected. Surgeons and medical teams using these implants for hip fracture treatment are at highest risk.
Check if your surgical implant has model numbers 903209125, 903209130, or 903209135. The product is used for hip fractures and is sold through medical suppliers.
Reach out to your surgeon to discuss the recall and potential medical review for the affected implant.
The device failed clinical analysis for survivorship, meaning it may not hold properly over time and could require additional surgery.
No specific stop-use instruction is provided; medical review is recommended instead.
Check for model numbers 903209125, 903209130, or 903209135 on your surgical implant.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1227-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1227-2018 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.
