FDA-Device2014-03-19Class II
Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Biomet 3i, LLC
Hazard
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Sold states
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.
Affected count
21
Manufactured in
4555 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1167-2014Don't want to check this manually?
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