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Biomet, Inc. recalls BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Recalled April 15, 2020 · FDA recall Z-1647-2020 · Biomet
Hazard
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. · FDA Class II
Units
230,001
Sold at
Worldwide distribution. US distribution to the following states: 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.
Description
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →