Duracon 6478-6-625Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327044904), received between May 19, 2020 and Jan 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• InjuryJan 6, 2025Degraded; Fracture; Detachment of Device or Device Component; Osseointegration Problem; Degraded; Fracture; Detachment of Device or Device Component; Osseointegration Problem

  STEM-GUIDED CTEP: FATIGUE OF THE FEMORAL COUPLING SITE BETWEEN THE STEM AND FEMORAL IMPLANT. SIGNIFICANT METALLOSIS IN THE JOINT, THE COUPLING POINT BETWEEN THE STEM AND THE FEMORAL COMPONENT IS CLEARLY LOOSENED. AXIAL DEVIATION AND ROTATIONAL INSTABILITY OF APPROX. 15 DEGREES THE FEMORAL COMPONENT CAN BE SALVAGED IN CONJUNCTION WITH THE STEM (OP ENDOGAP (B)(6) 2024). THE IMPLANT WAS TRANSFERRED TO THE PATIENT AT THE PATIENT'S REQUEST.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Metal Related Pathology

  MAUDE report 21080569 ↗
• InjuryMay 19, 2020Fracture; Fracture

  CUSTOMER INFORMED TO SALES REP THAT PHYSICIAN NOTICED FROM X-RAY THAT THE MRH PRESS-FIT STEM WAS BROKEN.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 10072515 ↗

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