BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Reported: April 15, 2020 Initiated: February 26, 2020 #Z-1647-2020
Product Description
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Reason for Recall
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 230,001
- Distribution
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.. Recalled by Biomet, Inc.. Units affected: 230,001.
Why was this product recalled? ▼
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 15, 2020. Severity: Moderate. Recall number: Z-1647-2020.
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