GENESIS II 71430260Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010212030), received between Feb 2, 2021 and Mar 14, 2021 — classified as 2 malfunctions.

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

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 16, 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.

• MalfunctionMar 14, 2021Crack; Material Discolored; Crack; Material Discolored

  IT WAS REPORTED THAT, SPACER TRIALS SEEM DECOLORATED AND CRACKED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478886 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT THE POLYS WERE OLD, WORN, AND STARTING TO CRACK. NO PATIENT INVOLVED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269056 ↗