Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BIOMET StageOne Hip Cement Spacer Mold with Insert Recalled by Biomet, Inc. Due to Potentially insufficient cleaning process or potential inadequate process...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomet, Inc. directly.
Affected Products
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
Quantity: 230,001
Why Was This Recalled?
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Where Was This Sold?
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.
About Biomet, Inc.
Biomet, Inc. has 250 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report