Duracon 6642-1-909Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540318282), received between Mar 13, 2019 and Mar 13, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K032163, K032418, K915512); 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.

• InjuryMar 13, 2019Unstable; Unstable

  REVISION OF A DURACON KNEE POLYETHYLENE INSERT FOR KNEE INSTABILITY. PATIENT HAD A 9MM XL DURACON INSERT IMPLANTED IN (B)(6) 2000 AND REVISED FOR INSTABILITY OF THE PATIENTS KNEE. ON (B)(6) 2019 THE REVISION SURGERY WAS COMPLETED AND SUCCESSFULLY REMOVED THE 9MM INSERT REPLACING IT WITH AN XL 11MM INSERT.

  Patient problems: Injury

  MAUDE report 8417153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032163, K032418, K915512. One submission often covers many models, so check the product and lot details in each record.

• Z-0917-2024 · Dec 1, 2023 · Open, Classified
  DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
• Z-0916-2024 · Dec 1, 2023 · Open, Classified
  DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
• Z-0918-2024 · Dec 1, 2023 · Open, Classified
  DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
• Z-1601-2009 · May 5, 2006 · Terminated
  Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Sterile; Howmedica Osteonics Corp. Stryker, Ireland. Product No. 6642-1-611. The device is used to replace bearing surface if t