GENESIS II 71420968Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010210142), received between May 24, 2019 and May 24, 2019 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K962137); 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.

• InjuryMay 24, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS REPORTED DUE TO FEMUR HAD JUMPED THE POST OF THE TIBIAL INSERT. INSERT WAS REMOVED.

  Patient problems: Injury

  MAUDE report 8640123 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962137. One submission often covers many models, so check the product and lot details in each record.

• Z-0118-2021 · Sep 21, 2020 · Terminated
  Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e.