Duracon 6742-1-309Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540324023), received between Aug 29, 2019 and Aug 29, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K012172); 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.

• InjuryAug 29, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO THE SCREW BACKING OUT OF THE INSERT. PRIMARY IMPLANT FACILITY IS UNKNOWN. REP PROVIDED A PICTURE OF THE DEVICE LABEL AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8945996 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012172. One submission often covers many models, so check the product and lot details in each record.

• Z-0924-2024 · Dec 1, 2023 · Open, Classified
  PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
• Z-0923-2024 · Dec 1, 2023 · Open, Classified
  PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411