STAGEONE 433165Recalls & 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.

7 other recalls cover devices cleared under the same FDA submission (K050210, K161273); 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-1666-2020 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050210, K161273. One submission often covers many models, so check the product and lot details in each record.

• Z-1668-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
• Z-1662-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
• Z-1663-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
• Z-1667-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
• Z-1669-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
• Z-1665-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
• Z-1664-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.