STAGEONE 431209Recalls & reported problems

Summary

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

2 FDA recall records name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K052990); 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-1654-2020 · Root cause: Process control · FDA record ↗

2. Sep 21, 2018Terminated

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

   Z-0399-2019 · Root cause: Error in labeling · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052990. One submission often covers many models, so check the product and lot details in each record.

• Z-1656-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
• Z-1655-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
• Z-1653-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.