Duracon 6478-6-725Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327045055), received between Jul 31, 2025 and Jul 31, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration

  INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: R DISTAL 1/3RD TIBIA FRACTURE. CLOSED REDUCTION AND CASTING UNDER MAC ANAESTHESIA. ALSO HAD IPSILATERAL ANKLE FRACTURE BETWEEN GMRS SURGERY AND LAST F/U VISIT WHERE FEMORAL STEM LOOSENING WAS DIAGNOSED. DECLINED DISCUSSION OF SURGERY AT LAST VISIT. HAD ORDER FOR PT AND PLAN WAS TO CONTINUE W THIS.

  Patient problems: Bone Fracture(s)

  MAUDE report 22673410 ↗

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