FDA-Device2020-04-15Class II
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Biomet, Inc.
Hazard
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Sold states
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.
Affected count
230, 001
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1642-2020Don't want to check this manually?
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