Duracon 6478-6-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327045017), received between Jul 19, 2023 and Jul 19, 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 16, 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 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGEON REPORTED THE NON-CONNECTION BETWEEN THE FEMORAL COMPONENT AND THE TAPROOT. POLIO PATIENT TREATED 3 MONTHS AGO FOR REVISION OF KNEE PROSTHESIS BY AFFIXING OF MRH SYSTEM. ABOUT THREE MONTHS AFTER THE OPERATION, THE PATIENT RETURNS FOR EXAMINATION AND THE COMPLETE DECOUPLING BETWEEN THE STEM AND THE FEMORAL COMPONENT IS DETECTED BY RADIOGRAPHIC EXAMINATION. THE FEMORAL PART WAS REVISED USING THE GMRS SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 17350025 ↗

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