FDAFDA · Food and drugs·Recall number Z-1169-2014
Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Published March 19, 2014 · Recall initiated: July 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet 3i, LLC
- Distributor
- 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.
- Lot
- NCATDO aka CATD0 (PSDT1)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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