NA 04.045.072Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982292995), received between Dec 1, 2021 and Feb 21, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REPAIR A PERIPROSTHETIC DISTAL FEMUR FRACTURE WITH A RETROGRADE FEMORAL NAIL AND SCREWS ON (B)(6) 2022. PATIENT WAS BROUGHT BACK TO THE OR TO REMOVE TWO DISTAL INTERLOCKING SCREWS THAT HAD BEGUN TO BACK OUT OF THE INTRAMEDULLARY NAIL ON (B)(6) 2023. THE TWO SCREWS WERE REMOVED EASILY AND NO FURTHER INTERVENTION WAS REQUIRED. THERE WAS PATIENT CONSEQUENCES DUE TO PAIN. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL 5/ 72/ XL25 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16409385 ↗
• InjuryDec 17, 2021Migration; Migration

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A UNKNOWN PROCEDURE. IT WAS NOTED THAT THE DISTAL LOCKING SCREW OF AN RFNA BACKED OUT. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR (1) LOCKING SCREW FOR IM NAIL 5/ 72/ XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 13026679 ↗
• MalfunctionDec 1, 2021Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING SCREW FOR MEDULLARY NAIL BACKED OUT. THE FEMORAL RECON NAIL SYSTEM WAS PLACED IN (B)(6) 2021. THE PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT INVOLVES ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 72MM/ XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 12909849 ↗

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 Adva
• 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 Adva