Duracon 6637-0-928Recalls & 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.

6 other recalls cover devices cleared under the same FDA submission (K940861); 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-0912-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K940861. One submission often covers many models, so check the product and lot details in each record.

• Z-0910-2024 · Dec 1, 2023 · Open, Classified
  LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
• Z-0909-2024 · Dec 1, 2023 · Open, Classified
  LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
• Z-0907-2024 · Dec 1, 2023 · Open, Classified
  LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
• Z-0908-2024 · Dec 1, 2023 · Open, Classified
  LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
• Z-0913-2024 · Dec 1, 2023 · Open, Classified
  RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
• Z-0911-2024 · Dec 1, 2023 · Open, Classified
  RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831