Genius Total Knee System 121-07-4004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09348215020309), received between Dec 9, 2018 and Dec 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K170613); 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.

Recalls naming this device

1. Dec 10, 2018Class IITerminated

   Product mix up

   Z-0833-2019 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

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.

• MalfunctionDec 9, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A CUSTOMER COMPLAINT WAS RECEIVED BY SIGNATURE ORTHOPAEDICS PTY LTD ON (B)(6) 2018 FROM SIGNATURE ORTHOPAEDICS USA REPRESENTATIVE STATING: "SIGNATURE US SALE REPRESENTATIVE REPORTED THAT OPENED SIZE 4 TIBIA BOX (121-07-4004) AND TO MY SURPRISE THERE WAS A SIZE 0 LEFT FEMUR (121-07-3000) IN THERE. ALSO THE STICKER WAS FOR SIZE 4 TIBIA."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8145383 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170613. One submission often covers many models, so check the product and lot details in each record.

• Z-0834-2019 · Dec 10, 2018 · Terminated
  Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component