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U.S. Department of Health and Human Services

Class 2 Device Recall BIOMET Orthopedics

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  Class 2 Device Recall BIOMET Orthopedics see related information
Date Initiated by Firm February 26, 2020
Date Posted April 03, 2020
Recall Status1 Terminated 3 on July 29, 2021
Recall Number Z-1670-2020
Recall Event ID 85153
Product Classification Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
Product BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.
Code Information Lot Number 800940 
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
Manufacturer Reason
for Recall
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
FDA Determined
Cause 2
Process control
Action On 2/26/2020, Zimmer Biomet sent an "Urgent Medical Device Recall" letter via FEDEX to direct sales distributors, hospitals, and surgeons. In addition, an email was sent to all distributors alerting them of the recall. Customers were instructed to quarantine the product and a Zimmer Biomet representative would remove the affected product from the facility. They asked customers to complete and return the "Certificate of Acknowledgement" form indicating whether they had any of the affected lots.
Quantity in Commerce 1
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.