NA 04.045.050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982292827), received between Sep 8, 2022 and Sep 8, 2022 — classified as 3 injuries.

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 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.

• InjurySep 8, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL SURGERY OF THREE INTERLOCKING SCREWS. BOTH OBLIQUE INTERLOCKING SCREWS AND DISTAL INTERLOCKING SCREW HAVE BACKED OUT OF RFN-A. ORIGINAL SURGERY WAS (B)(6) 2022, SURGEON REPORTS SEEING THEM BACKING OUT AS OF (B)(6) 2022. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5 MM/ 50 MM/ XL25. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15378921 ↗
• InjurySep 8, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL SURGERY OF THREE INTERLOCKING SCREWS. BOTH OBLIQUE INTERLOCKING SCREWS AND DISTAL INTERLOCKING SCREW HAVE BACKED OUT OF RFN-A. ORIGINAL SURGERY WAS (B)(6) 2022, SURGEON REPORTS SEEING THEM BACKING OUT AS OF (B)(6) 2022. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5 MM/ 50 MM/ XL25. THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 15378915 ↗
• InjurySep 8, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6), 2022, THE PATIENT UNDERWENT A REMOVAL SURGERY OF THREE INTERLOCKING SCREWS. BOTH OBLIQUE INTERLOCKING SCREWS AND DISTAL INTERLOCKING SCREW HAVE BACKED OUT OF RFN-A. ORIGINAL SURGERY WAS (B)(6) 2022, SURGEON REPORTS SEEING THEM BACKING OUT AS OF (B)(6) 2022. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 50MM/ XL25. THIS IS REPORT 1 OF 3 FOR (B)(4).

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

  MAUDE report 15378914 ↗

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