GENESIS II 71430238Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010211927), received between Aug 17, 2020 and Mar 8, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 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 8, 2021Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE GENESIS II INSERT SPACER SIZE 7-8, 15MM WAS NOTICED TO BE WORN OUT AND BROKEN. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431763 ↗
• InjuryAug 17, 2020Break; Break

  IT WAS REPORTED THAT DURING USE IN SURGERY THE G2 INS SPAC TR SZ7-8 15MM BROKE INTO TWO PIECES INSIDE THE PATIENT. NO DELAY. PROCEDURE WAS FINISHED USING A S&N BACK UP DEVICE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10418041 ↗