Biomet 3i, LLC: Medical Device Recall in 2014 - (Recall #: Z-1170-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

Product Classification:

Class II

Date Initiated: July 22, 2013

Date Posted: March 19, 2014

Recall Number: Z-1170-2014

Event ID: 67183

Reason for Recall:

During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

Status: Terminated

Product Quantity: 250

Code Information:

NCATD0C (PSDT1)

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.

Voluntary or Mandated:

Voluntary: Firm initiated