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U.S. Department of Health and Human Services

Class 2 Device Recall BIOMET MICROFIXATION Trauma One SYSTEM

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  Class 2 Device Recall BIOMET MICROFIXATION Trauma One SYSTEM see related information
Date Initiated by Firm February 16, 2009
Date Posted September 08, 2009
Recall Status1 Terminated 3 on November 05, 2009
Recall Number Z-1949-2009
Recall Event ID 52672
Product Classification Bur, dental - Product Code EJL
Product BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.
Code Information Lot Numbers: 619450 and JC1002.   
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Christy Cain
904-741-4400
Manufacturer Reason
for Recall		 Biomet Microfixation is recalling the 46-1004, Trauma One Drill, 18.x115 mm, 26 mm Stop Lot Numbers 619450 and JC1002. The drills may be color-banded blue instead of brown. The color is a visual aid in determining what system the drill goes with. The blue indicates the drill is for the 2.0mm system. The brown indicates the drill is to be used for our 2.3mm system. The drill is etched and labe
FDA Determined
Cause 2		 Process control
Action Biomet Microfixation, Inc. issued an Urgent Medical Device Recall Notice dated February 19, 2009 via certified mail with return receipt. The notice informed users of the affected device and instructed them to immediately discontinue use and return to the firm. Consignees were also instructed to complete and return an Inventory Reconciliation sheet via fax to 1-904-741-9425. For further information, contact Biomet Microfixation, Inc. at 1-800-874-7711 or 1-904-741-4400.
Quantity in Commerce 79
Distribution Nationwide Distribution -- Texas, Maryland, Florida, Washington DC, Michigan, Kansas Colorado and Missouri.
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.
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