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STAGEONERecalls & reported problems across all models

Biomet Orthopedics, LLC · 17 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
18

We found 17 models of STAGEONE by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

18 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

STAGEONE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1669-2020 · Root cause: Process control · Recall details · FDA record ↗

  2. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1668-2020 · Root cause: Process control · Recall details · FDA record ↗

  3. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1667-2020 · Root cause: Process control · Recall details · FDA record ↗

  4. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1666-2020 · Root cause: Process control · Recall details · FDA record ↗

  5. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1665-2020 · Root cause: Process control · Recall details · FDA record ↗

  6. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1664-2020 · Root cause: Process control · Recall details · FDA record ↗

  7. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1663-2020 · Root cause: Process control · Recall details · FDA record ↗

  8. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1662-2020 · Root cause: Process control · Recall details · FDA record ↗

  9. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1661-2020 · Root cause: Process control · Recall details · FDA record ↗

  10. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1660-2020 · Root cause: Process control · Recall details · FDA record ↗

  11. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1659-2020 · Root cause: Process control · Recall details · FDA record ↗

  12. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1658-2020 · Root cause: Process control · Recall details · FDA record ↗

  13. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1657-2020 · Root cause: Process control · Recall details · FDA record ↗

  14. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1656-2020 · Root cause: Process control · Recall details · FDA record ↗

  15. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1655-2020 · Root cause: Process control · Recall details · FDA record ↗

  16. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1654-2020 · Root cause: Process control · Recall details · FDA record ↗

  17. Feb 26, 2020Terminated

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Z-1653-2020 · Root cause: Process control · Recall details · FDA record ↗

  18. Sep 21, 2018Terminated

    There is a potential for comingling of the 43MM and 51 MM molds

    Z-0399-2019 · Root cause: Error in labeling · names 2 of these models · Recall details · FDA record ↗

STAGEONE models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

Other Biomet Orthopedics, LLC products

All Biomet Orthopedics, LLC devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page