Duracon 6642-1-625Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540318138), received between Feb 27, 2019 and Feb 27, 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 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.

• InjuryFeb 27, 2019Unstable; Unstable

  AS REPORTED: "PATIENT COMPLAINS OF STABILITY ISSUES". PATIENT'S RIGHT KNEE WAS REVISED 21 YEARS POST IMPLANT. A DURACON INSERT WAS SWAPPED FOR A 25 AP LIPPED INSERT. PRIOR TO PRIMARY IMPLANT, PATIENT HAS A HISTORY OF A "TIB-FIB FRACTURE" AS THE RESULT OF A MOTOR VEHICLE ACCIDENT WITH COMORBIDITIES OF DEGENERATIVE ANKLE DISEASE, MORBID OBESITY, HYPERTENSION, AND GLAUCOMA. REP PROVIDED X-RAYS, PRIMARY OPERATIVE REPORT, EXPLANT PICTURES, AND VITALS AND REPORTED THAT ALL INFORMATION AVAILABLE TO HIM HAS BEEN SUBMITTED.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8373754 ↗

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