NA 04.233.232SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982290854), received between Mar 19, 2022 and May 29, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 other recalls cover devices cleared under the same FDA submission (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 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR NON-UNION, DEVICE RELATED: POSSIBLE, PROCEDURE RELATED: PROBABLE, DATE OF EVENT: 02 MAY 2025, DATE OF IMPLANT: (B)(6) 2024, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: SURGICAL INTERVENTION AT THE FRACTURE SITE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22104239 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED (B)(6) 2024 DUE TO A MALUNION/NONUNION. SURGEON REMOVED ALL IMPLANTS THAT WERE CURRENTLY IN PATIENT. RIA WAS USED TO COLLECT BONE GRAFT AND CLEAN OUT THE SURGICAL SITE. SURGEON INSERTED NEW IMPLANTS AFTER RESTORING ALIGNMENT AND LENGTH. ORIGINAL IMPLANT DATE UNKNOWN. IT IS NOT KNOWN HOW LONG THE DEVICES HAVE BEEN IMPLANTED FOR. THIS REPORT IS FOR ONE RFNA/ 12MM/ 320MM/ STANDARD BEND/ STER FOR (B)(4).

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

  MAUDE report 19042819 ↗
• InjuryMar 19, 2022Device Dislodged or Dislocated; No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDER A HARDWARE REMOVAL PROCEDURE TO REMOVE THE LATERAL OBLIQUE LOCKING SCREW OF THE RETROGRADE FEMORAL NAIL ADVANCED (RFNA) BECAUSE IT HAD BACKED OUT. THIS REPORT IS FOR A RFNA NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13824280 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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