NA 71362748Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010456861), received between Oct 8, 2020 and Apr 12, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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. How this data works · Data updated Oct 13, 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.

• InjuryApr 12, 2021Break; Break

  IT WAS REPORTED THAT DURING TOTAL HIP REPLACEMENT THE REAMER CROSSBAR FAILED AT ITS WELD WITH THE REAMER BASKET DUE TO FATIGUE. NO DELAY OR INJURY OCCURRED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648456 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED THAT THE REAMER DOME CROSS BAR BROKE OFF THE REAMER DOME. IT IS UNKNOWN IF THIS OCCURRED DURING THE PROCEDURE OR IF THERE WAS ANY DELAY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10652660 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116