Duracon 6478-6-695Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327045000), received between Jul 30, 2025 and Aug 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE WOUND INFECTION. INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: WOUND INFECTION SUSPECTED (B)(6) 2013, IV VANC, NO RETURN TO OR. LATER NEEDED TO BE ON LIFELONG ORAL ANTIBIOTICS FOR CHRONIC SUPPRESION.

  Patient problems: Unspecified Infection

  MAUDE report 22724384 ↗
• InjuryJul 30, 2025Fracture; Fracture

  INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: BROKEN TIBIAL STEM. TIBIAL COMPONENTS REMOVED. RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22663182 ↗

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