Duracon 6642-1-811Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540318220), received between Sep 18, 2019 and Sep 18, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjurySep 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE LEFT KNEE. PATIENT CALLED STATING SHE HAD BILATERAL KNEE REPLACEMENTS DONE. SHE REPORTED PAIN, SWELLING, DIFFICULTY WALKING AND DISCOMFORT. PATIENT WOULD LIKE TO KNOW IF HER IMPLANTS ARE PART OF A RECALL.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling

  MAUDE report 9082271 ↗

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-0918-2024 · Dec 1, 2023 · Open, Classified
  DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
• 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-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