StageOne Select 431195Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304521124), received between Dec 6, 2023 and Dec 6, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier.

14 other recalls cover devices cleared under the same FDA submission (K080979, K161166, K222760); 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-1648-2020 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2023Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Pain

  MAUDE report 18278146 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080979, K161166, K222760. One submission often covers many models, so check the product and lot details in each record.

• Z-1647-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
• Z-1642-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
• Z-1641-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
• Z-1645-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
• Z-1651-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
• Z-1650-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
• Z-1643-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
• Z-1652-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
• Z-1638-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
• Z-1640-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
• Z-1644-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
• Z-1649-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
• Z-1639-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
• Z-1646-2020 · Feb 26, 2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.