NA 04.045.090SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982294678), received between Jan 23, 2024 and May 23, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT ORIGINALLY UNDERWENT AN RFNA SURGERY ON (B)(6) 2024; TWO LOCKING SCREWS WERE INSERTED IN THE DISTAL FEMUR. THE PATIENT COMPLAINED OF PAIN AND UNDERWENT A REMOVAL SURGERY ON (B)(6) 2025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: Pain

  MAUDE report 22078241 ↗
• InjuryJan 23, 2024Migration; Migration

  IT WAS FURTHER REPORTED: THE NAIL WAS IMPLANTED ON (B)(6) 2023. THERE WAS NO ALLEGATION AGAINST THE NAIL. THE 2 DISTAL ML SCREWS BACKED OUT OF THE 2ND AND 3RD SCREW HOLES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BACKED OUT SCREWS WERE EXCHANGED.

  Patient problems: Insufficient Information

  MAUDE report 18566192 ↗
• InjuryJan 23, 2024Migration; Migration

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, A REVISION OF TWO RFNA DISTAL SCREWS WAS PERFORMED. ONE MEDIAL TO LATERAL SCREW BACKED OUT AND ONE MEDIAL TO LATERAL SCREW CUT IN. IT REQUIRED EXCHANGED OF SCREWS. THE EXPLANTATION WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 90MM/ XL25/ STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18566189 ↗

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