STAGEONE 431408Recalls & 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.

4 other recalls cover devices cleared under the same FDA submission (K131135, K160071); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 26, 2020Terminated

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

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

Recalls under the same FDA submission

These recalls involve devices cleared under K131135, K160071. One submission often covers many models, so check the product and lot details in each record.

• Z-1660-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
• Z-1659-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
• Z-1657-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
• Z-1661-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.