Device product
Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Z-1171-2014
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 67183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 181
- Official record key
device-enforcement:Z-1171-2014
Official wording
Reason: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Code information: NPSDK0 aka PSKDO (PSKDT1)(
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.
Derived failure modes
-
Unknown
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.