Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1648-2020·Announced 2020-04-15

Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

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

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, and the source text does not report any illnesses, injuries, or hospitalizations, 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 w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195. The recall is being conducted 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 within 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.

Healthcare providers and patients should check their inventory and patient records for the specific lot numbers and UDI numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Biomet, Inc. according to their instructions.

The recalled product

Product: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
Manufacturer: Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: inadequate-cleaning
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*** 978870
104900
469480
804270
254080
573990
574110
437220
794520
084260
474130
321640
697120
767230
843180
021340
953860
348180
916270
167360

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 →

Same manufacturer · Biomet, Inc.

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Same hazard · inadequate cleaning