Duracon 6642-1-809Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540318213), received between Jun 17, 2019 and Jun 17, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (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 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.

• InjuryJun 17, 2019Naturally Worn; Naturally Worn

  AS REPORTED: "[REVISION DUE TO] WEAR OF TIBIAL BEARING COMPONENT. STIFF KNEE - LEFT". UPDATE ON 16 JULY, 2019: THE OPERATIVE REPORT NOTES, ¿THERE WAS NEAR WEAR-THROUGH BOTH MEDIALLY AND LATERALLY ON THE TIBIAL PLASTIC¿. THE INSERT WAS CHANGED TO A NEW AP LIPPED LARGE 9MM DURACON INSERT AND THE PATELLAR COMPONENT WAS CHANGED TO A 36 X3 SYMMETRICAL CEMENTED COMPONENT." THE MEDICAL REVIEW CONCLUDED THAT "AFTER MORE THAN TWENTY-TWO YEARS IN SITU WITH POLYETHYLENE INSERTS AVAILABLE AT THAT TIME, INSERT WEAR IS NOT UNEXPECTED. THERE IS NO INDICATION THIS LATE CLINICAL EVENT WAS RELATED TO FACTORS ASSOCIATED WITH FAULTY COMPONENT DESIGN, MANUFACTURING OR MATERIALS."

  Patient problems: Injury

  MAUDE report 8703828 ↗

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-0916-2024 · Dec 1, 2023 · Open, Classified
  DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
• 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-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