The Recall Desk
ModerateFDA (Devices)·Z-1645-2020·Announced 2020-04-15

Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

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 indicates a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is related to process monitoring rather than a confirmed defect causing harm, fitting the criteria for a moderate severity score.

Plain-English summary

Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Select Hip Stem Cement Spacer Mold with Reinforcement Cement (13 x 145 mm, Silicone, Sterile, Item 431192). 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 to specific states in the United States, including Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia. The recall covers numerous specific lot numbers and UDI numbers listed in the official FDA record.

This is an FDA Class II recall. No illnesses or injuries have been reported in the source text. Healthcare providers and patients should contact Biomet, Inc. for further instructions on how to handle the affected devices.

The recalled product

Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
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*** 838930
  • 799860
  • 764700
  • 371690
  • 371700
  • 574530
  • 062130
  • 939190
  • 258290
  • 874960
  • 717990
  • 135090
  • 341030
  • 262420
  • 789510
  • 843130
  • 843140
  • 020980
  • 063530
  • 258130

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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