Duracon 6642-1-709Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Dec 1, 2023Open, Classified

   Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

   Z-0916-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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-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