Zimmer Biomet recalls ACE Trochanteric Nail System models with specific dimensions due to device performance failure in clinical analysis.
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 several ACE Trochanteric Nail System models after clinical analysis failed to meet performance criteria. This could affect surgical outcomes if used without correction.
The device performance review failed clinical analysis for survivorship, meaning the nails may not function as intended after surgery. This could lead to complications if the device does not meet required performance standards.
Patients who have undergone hip surgery using these specific nail models are most at risk. The recall targets medical devices used in surgical procedures.
Check for the specific model numbers listed in the recall notice, which include dimensions like 320X9X125, 340X9X125, and other combinations. The product is used in hip surgery.
Reach out to Zimmer Biomet directly for guidance on the recall and next steps.
The device performance review failed clinical analysis for survivorship, meaning the product may not meet required performance standards.
The recall includes specific dimensions like 320X9X125, 340X9X125, 360X9X125, and other combinations listed in the product names.
The recall does not specify a stop-use instruction; contact Zimmer Biomet for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1235-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1235-2018 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.
