NA 04.045.084Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982293053), received between Nov 12, 2021 and Apr 18, 2023 — 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.

• InjuryApr 18, 2023Migration; Migration

  IT WAS REPORTED THAT AN INTRAMEDULLARY RETROGRADE FEMORAL NAIL (RFNA STANDARD BEND/5 DEGREES 12X340) WAS INSERTED ON (B)(6) 2022 AND INTERLOCKING SCREWS WERE PLACED DISTALLY AND PROXIMALLY. TWO OF THE DISTAL INTERLOCKING SCREWS (IN THE OBLIQUE HOLES) BACKED OUT OVER TIME. THE PATIENT CAME TO THE ER ON (B)(6) 2023 AND COMPLAINED OF THE PROMINENCE AFTER BUMPING HER KNEE. ONE OF THE SCREW HEADS WAS PROTRUDING THROUGH THE SKIN. THE PROTRUDING SCREW WAS REMOVED IN THE ER, AND THE SECOND OBLIQUE SCREW WAS REMOVED DURING AN INCISION AND DRAINAGE CASE THE SAME DAY. THERE WAS NO DELAY IN SURGERY. THE SURGEON STATED THAT THE FRACTURE APPEARED TO BE HEALED RADIOGRAPHICALLY. THERE ARE NO OTHER KNOWN ISSUES WITH THE PATIENT. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 84MM/ XL25 THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 16763263 ↗
• InjuryNov 12, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY AND HARDWARE REMOVAL DUE TO MIGRATION OF THE LOCKING SCREW. THERE WAS SCREW PROMINENCE AND POTENTIAL LOSS OF FIXATION. THE SCREW BACKED OUT TWO (2) MONTHS AFTER INSERTION. THE PRODUCT WAS IMPLANTED IN THE PATIENT ON (B)(6) 2021. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL 5/ 84/ XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 12802804 ↗

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-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
• 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