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Recall Observatory FDA recall evidence

Device product

Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

Z-1168-2014

July 22, 2013

Class II

Product summary

Firm
Biomet 3i, LLC
Event
Event 67183
Status
Terminated
Classification
Class II
Quantity
170
Official record key
device-enforcement:Z-1168-2014

Official wording

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

Code information: SGTIKIT (SGTTRAY)

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

    reason.no_named_rule · v1.0.0

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