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U.S. Department of Health and Human Services

Class 2 Device Recall ContraAngle Torque Driver Kit

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  Class 2 Device Recall ContraAngle Torque Driver Kit see related information
Date Initiated by Firm July 22, 2013
Date Posted March 12, 2014
Recall Status1 Terminated 3 on April 21, 2015
Recall Number Z-1169-2014
Recall Event ID 67183
Product Classification General surgery tray (kit) - Product Code LRO
Product Contra-Angle Torque Driver Kit

Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Code Information NCATDO aka CATD0 (PSDT1)
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Biomet Customer Service
800-342-5454
Manufacturer Reason
for Recall		 During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Biomet 3i sent an Urgent Medical Device Field Correction Notice dated July 2013 to all affected customer via email, facsimile, or postal mail. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to complete the attached response form and fax to 561-514-6316. For questions contact Biomet 3i customer service at 1-800-342-5454.
Quantity in Commerce 541
Distribution Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.
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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