NA 04.045.070SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982294579), received between May 1, 2023 and May 1, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2023Migration; Migration

  IT WAS NOTED THE FRACTURE PATTERN WAS CHALLENGING/UNSTABLE AND THE SURGEON MENTIONED THAT SCREW BACK OUT FOLLOWING THESE CASES IS NOT UNEXPECTED. THE PATIENT WAS COMPLIANT FOLLOWING IMPLANTATION AS FAR AS THE HEALTH CARE PROVIDERS WERE AWARE. IT WAS MENTIONED IT WAS CONFIRMED THE CORRECT TECHNIQUE WAS USED FOR SCREW INSERTION.

  Patient problems: Pain

  MAUDE report 16845270 ↗

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