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Biomet 3i, LLC recalls Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments
Recalled March 19, 2014 · FDA recall Z-1168-2014 · Biomet 3i
Hazard
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. · FDA Class II
Units
170
Sold at
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.
Description
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Product
Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Manufacturer(s)
Biomet 3i, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →