The Recall Desk
ModerateFDA (Devices)·Z-1650-2020·Announced 2020-04-15

Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) in the absence of reported injuries, hospitalizations, or Class I classification.

Plain-English summary

Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197. The recall was initiated because of a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

The affected products were distributed worldwide and in the United States to 48 states and the District of Columbia. The recall covers specific lot numbers and UDI numbers listed in the official FDA record Z-1650-2020.

Healthcare providers and patients should contact Biomet, Inc. for further instructions on how to handle the recalled devices. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
230,001

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • ***Lot Numbers*** 331870
  • 050670
  • 628200
  • 977700
  • 487840
  • 680310
  • 062930
  • 437310
  • 736420
  • 129860
  • 084270
  • 262430
  • 474140
  • 176350
  • 520540
  • 957200
  • 265730
  • 713220
  • 584750
  • 817700

Distribution

Distributed in 49 states:

Part of a larger recall action

This product is one of 33 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 33 products in this recall →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · inadequate cleaning

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