The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1669-2020·Announced 2020-04-15

Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns

Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 source text does not report any illnesses, injuries, or hospitalizations, and the hazard is described as a potential process issue 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 Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180. The recall was initiated due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

The affected products were distributed worldwide. In the United States, distribution included 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 specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the use of these devices.

The recalled product

Product
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
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*** 164050
  • 200280
  • 200310
  • 792540
  • 417400
  • 768490
  • 907050
  • 036500
  • 318820
  • 527430
  • 527420
  • 600560
  • 600570
  • 793200
  • 857880
  • 977030
  • 074710
  • 145290
  • 239380
  • 367730

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 →

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