SIMPLY ICONIC™ Implant 674716NPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307125952), received between Aug 7, 2024 and Mar 25, 2026 — classified as 4 injuries.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Positioning Failure; Osseointegration Problem

  LACK OF STABILITY DURING PLACEMENT.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24692113 ↗
• InjuryMar 25, 2026Positioning Failure; Osseointegration Problem

  LACK OF STABILITY DURING PLACEMENT.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24692109 ↗
• InjuryFeb 5, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  USABILITY - WRONG PART USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21316365 ↗
• InjuryAug 7, 2024Premature Separation; Premature Separation

  CUSTOMER STATES "PART NOT RETAINED ON MATING PART", CUSTOMER CLAIM INDICATES, FAILURE OF OSSEOINTEGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929005 ↗