The Recall Desk
ModerateFDA (Devices)·Z-1657-2020·Announced 2020-04-15

Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

Biomet is recalling 230,001 units of StageOne Shoulder 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. The hazard involves process monitoring and cleaning parameters, which is a quality control issue. No illnesses or injuries are reported, and the risk is theoretical, fitting the criteria for a moderate severity score.

Plain-English summary

Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406. 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 source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices. No illnesses or injuries are reported in the source text.

The recalled product

Product
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
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*** 860650
  • 215420
  • 555520
  • 583840
  • 089450
  • 283340
  • 132840
  • 413160
  • 058040
  • 181870
  • 408950
  • 409050
  • 409080
  • 851260
  • 234340
  • 338950
  • 581670
  • 201250
  • 518970
  • 024030

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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