BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209

Biomet, Inc. began a recall of BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209 on 2020-02-26. FDA classified it as Class II and gives the reason as "Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.