NA 04.233.216SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982290809), received between Jan 9, 2023 and Jan 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 WHILE VERIFYING SET CONTENTS PRIOR TO SURGERY IT WAS NOTED THAT A NAIL WAS MISSING FROM STERILE TOTE RFNA 5 DEGREE OUTLIERS. STERILE TOTE RFNA 5 DEGREE OUTLIERS WAS ZIP-TIED WITH A BLACK ZIP TIE INDICATING IT WAS A COMPLETE SET. STERILE TOTE RFNA 5 DEGREE OUTLIERS WAS NOT WITHIN PHYSICAL J&J CONTROL. THERE WAS NO IMPACT TO PATIENT AS THE MISSING PART WAS NOT NEEDED FOR THE SCHEDULED SURGERY. SURGEON UTILIZED A DIFFERENT SIZE AND TYPE OF NAIL FOR PROCEDURE. DECISION WAS NOT A DIRECT RESULT OF THE MISSING NAIL. A COMPLAINT IS REQUIRED AS THE LOANER SET WAS UNEXPECTEDLY INCOMPLETE WITH NO SURGERY PLAN IMPACT AND NO PATIENT IMPACT. SET RECEIVED AT HOSPITAL AND HOSPITAL ABLE TO USE SET WITHOUT FURTHER J&J ACTION.THIS REPORT IS FOR ONE (1) RFNA/ 12MM/ 160MM/ STANDARD BEND/ STER.THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16124359 ↗

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-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