NA 04.233.234SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982290861), received between May 18, 2021 and Jan 7, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RFNA/ 12MM/ 340MM/ STANDARD BEND/ STER AND UNK - SCREWS: LOCKING WERE INVOLVED IN AN EVENT. THE REPORTED FAILURE INCLUDED A NONUNION OF A FEMORAL FRACTURE FOLLOWING FIXATION WITH A RETROGRADE FEMORAL NAIL AND MULTIPLE INTERLOCKING SCREWS. DURING REVISION SURGERY, THE NAIL AND SCREWS WERE REMOVED AND REPLACED WITH A DISTAL FEMUR REPLACEMENT. OF THE FOUR DISTAL SCREWS, ONE WAS BACKING OUT AND TWO WERE BROKEN. THE EVENT REQUIRED A CORRECTIVE INVASIVE PROCEDURE TO REPLACE THE DEVICE. THE IMPLANT WAS EXPLANTED AND IS NOT AVAILABLE FOR RETURN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23989271 ↗
• InjuryMay 18, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6), 2021 THAT PATIENT UNDERWENT THE ORIGINAL SURGERY. THE PATIENT WAS SEEN ON (B)(6), 2021 FOR A FOLLOW UP AND POST OP X RAYS. IT WAS DISCOVERED THAT THE MOST DISTAL SCREW HAD ADVANCED AND WAS BOTHERING THE PATIENT. THE PATIENT WILL BE REVISED WITH A NEW SCREW AND END CAP TO LOCK THE DISTAL SCREW. THIS REPORT IS FOR ONE (1) RFNA / 12MM / 340MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 11843421 ↗

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