Duracon 6478-6-645Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327044942), received between Sep 29, 2023 and Sep 29, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

• InjurySep 29, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  FRACTURE OF THE FEMORAL SHAFT FROM THE MRH FEMUR. ADDITIONAL INFORMATION: THE STEM WITH MRH FEMUR WAS IMPLANTED PROPERLY IN 2016, FEMUR CEMENTED, STEM CEMENTLESS. THE PATIENT COMPLAINED OF PAIN IN 2023, SO A REVISION WAS NECESSARY. DURING THIS OP. IT WAS DISCOVERED THAT THE FEMORAL STEM WAS FRACTURED AT THE THREADED ATTACHMENT FROM THE FEMORAL COMPONENT.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17841655 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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