GENESIS II 71934387Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556084182), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 injury.

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.

• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, IN WHICH A GII CONST INSRT W/JRNY LOCK SZ 5-6 15MM HAD BEEN IMPLANTED, THE PATIENT'S KNEE WAS UNSTABLE; AS SUCH, A THICKER INSERT WAS NEEDED. THIS WAS EVALUATED CLINICALLY AND LATER CONFIRMED INTRAOPERATIVELY VIA A REVISION SURGERY, ON (B)(6) 2023, IN WHICH A THICKER SMITH AND NEPHEW INSERT WAS IMPLANTED. THE NEW INSERT WENT IN PROPERLY AND THE SURGEON BELIEVES THIS ADDRESSED THE PATIENT'S INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 17389813 ↗

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.