NA 04.045.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982292759), received between Jun 17, 2021 and Jun 17, 2021 — classified as 1 injury.

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 16, 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.

• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REVISION DUE TO LOSS OF FIXATION. WE WERE MADE AWARE OF A REVISION OF IMPLANTS THAT'S SHOULD BEEN IMPLANTED ON (B)(6) 2021. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES (7) DEVICES. THIS REPORT IS FOR (1) LOCKING SCREW FOR IM NAIL 5/ 36/ XL25. THIS REPORT IS 2 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12021214 ↗

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 Adva
• 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 Adva