NA 04.045.080SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982294623), received between Sep 14, 2022 and Nov 14, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A FRACTURE OF THE DISTAL SHAFT OF THE FEMUR. 4 LOCKING SCREWS WERE INSERTED INTO THE DISTAL HOLES, 2 LOCKING SCREWS WERE INSERTED INTO THE PROXIMAL HOLES, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2023, THE PATIENT COMPLAINED PAIN ON THE LATERAL OF THE DISTAL FEMUR AND THE X-RAYS WERE TAKEN. THE X-RAYS SHOWED THAT THE SCREW INSERTED IN THE MOST DISTAL HOLE BACKED OUT BY APPROXIMATELY 15 MM. THE SURGEON MADE PLANS TO REMOVE THE SCREW THAT BACKED OUT ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25/ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 18129832 ↗
• InjuryMar 20, 2023Migration; Migration

  AN ADVERSE EVENT HAS BEEN REPORTED IN THE DATABASE FOR CLINICAL STUDY DST202103 SUBJECT 01423-002 FOR AE TERM: RIGHT DISTAL FEMUR FRACTURE NON-UNION. THIS REPORT IS FOR ONE UNK - SCREWS: TRAUMA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16571713 ↗
• InjurySep 27, 2022Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW BACKED OUT. THE DEVICE WAS EXPLANTED. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25/ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15490865 ↗
• InjurySep 14, 2022Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW BACKED OUT. THE DEVICE WAS EXPLANTED. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25/ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15419706 ↗

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