Duracon 6478-6-490Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327050257), received between Jun 27, 2023 and Jun 27, 2023 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K060360, K223069, K973164); 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.

• InjuryJun 27, 2023Fracture; Fracture

  THE FOLLOWING WAS REPORTED, "5TH JUNE CASE: THE FEMORAL COMPONENT WAS REMOVED AND THE STEM HAD FRACTURED OFF AT THE JUNCTION OF THE 4MM OFFSET ADAPTER. THE TIBIAL COMPONENT WAS RETAINED AND A GMRS DISTAL FEMORAL CONSTRUCT WAS IMPLANTED."

  Patient problems: Insufficient Information

  MAUDE report 17213348 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060360, K223069, K973164. One submission often covers many models, so check the product and lot details in each record.

• Z-0362-2016 · Sep 21, 2015 · Terminated
  Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, m