| Class 2 Device Recall Navigator Surgical Kit | |
Date Initiated by Firm | July 22, 2013 |
Date Posted | March 12, 2014 |
Recall Status1 |
Terminated 3 on April 21, 2015 |
Recall Number | Z-1167-2014 |
Recall Event ID |
67183 |
Product Classification |
General surgery tray (kit) - Product Code LRO
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Product | Navigator Surgical Kit
Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. |
Code Information |
SGKIT (SGTRAY) |
Recalling Firm/ Manufacturer |
Biomet 3i, LLC 4555 Riverside Dr Palm Beach Gardens FL 33410-4200
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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 | 21 |
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 |
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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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