NA 04.045.056Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982292919), received between Mar 24, 2022 and Aug 28, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K201336, K201346); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Migration; Migration

  IT WAS REPORTED THAT ON JULY 30, 2024 A PATIENT UNDERWENT THE REMOVAL PROCEDURE DUE TO INTRAMEDULLARY SCREW BACK OUT OF RETROGRADE FEMORAL NAIL ADVANCED (RFNA). NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 56MM/ XL25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20091465 ↗
• InjuryMar 24, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT A REVISION OF RETROGRADE FEMORAL NAILING-ADVANCED SYSTEM (RFNA) DUE TO THREE (3) SCREWS BACKING OUT IN THE DISTAL PORTION OF THE NAIL. ALL SCREWS WERE REMOVED. A DISTAL FEMUR PLATE WAS ADDED FOR FIXATION OF THE FRACTURE AND THE NAIL WAS LEFT IN AS WELL. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 56MM/ XL25. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13892255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336, K201346. One submission often covers many models, so check the product and lot details in each record.

• Z-0229-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail A
• Z-0228-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail A