NA 04.233.124SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982290618), received between May 3, 2022 and Mar 6, 2026 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K201346, K233696); 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.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT WAS REVISED AND HARDWARE WERE REMOVED DUE TO NON-UNION AND MAL-UNION

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 24531212 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A HARDWARE REMOVAL OF A RETROGRADE FEMORAL NAIL -ADVANCED SYSTEM (RFNA) NAIL CONSTRUCT AND A VARIABLE ANGLE (VA) CONDYLAR PLATE CONSTRUCT WERE REMOVED FROM A FEMUR BECAUSE OF INFECTION. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2022 AND EXPLANTED ON (B)(6) 2022. NO ALLEGATIONS WERE MADE ON THE DEVICES FROM THE SURGEON. THE SURGEON REMOVED THE PROXIMAL SCREWS, AND PERFORMED AN AMPUTATION TO REMOVE REMAINING HARDWARE ON ONE PIECE. THE EXACT TOTAL NUMBER OF IMPLANTED SCREWS REMOVED IS UNKNOWN. THE PROCEDURE OUTCOME WAS UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR A RFNA NAIL.

  Patient problems: Unspecified Infection

  MAUDE report 14270132 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201346, K233696. 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