GENESIS II 71934385Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556084083), received between Sep 6, 2018 and Sep 9, 2018 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2018Component Missing; Component Missing

  IT WAS REPORTED A MALFUNCTION IN WHICH THERE A DELAY OVER THIRTY MINUTES. THE LEGION CROSS OVER WITH JOURNEY II LOCK DIDN'T HAVE THE DIVETS IN THE POLY FOR THE USE OF THE JOURNEY II GUN FOR INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7858736 ↗
• MalfunctionSep 6, 2018Component Missing; Component Missing

  IT WAS REPORTED A MALFUNCTION IN WHICH THE LEGION CROSS OVER WITH JOURNEY II LOCK DIDN'T HAVE THE DIVETS IN THE POLY FOR THE USE OF THE JOURNEY II GUN FOR INSERTION. DELAY LONGER THAN THIRTY MINUTES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7851634 ↗

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.