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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Event Detail

Event ID 67183
Product Type Devices
Status Ongoing
Recalling Firm Biomet 3i, LLC
City Palm Beach Gardens
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-22
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. SGTIKIT (SGTTRAY) Class II During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. 170 Z-1168-2014
Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. SGKIT (SGTRAY) Class II During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. 21 Z-1167-2014
Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. NCATDO aka CATD0 (PSDT1) Class II During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. 541 Z-1169-2014
Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. NPSDK0 aka PSKDO (PSKDT1)( Class II During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. 181 Z-1171-2014
Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. NCATD0C (PSDT1) Class II During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. 250 Z-1170-2014
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