Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Reported: March 19, 2014 Initiated: July 22, 2013 #Z-1168-2014
Product Description
Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Reason for Recall
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Details
- Recalling Firm
- Biomet 3i, LLC
- Units Affected
- 170
- Distribution
- 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.
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.. Recalled by Biomet 3i, LLC. Units affected: 170.
Why was this product recalled? ▼
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2014. Severity: Moderate. Recall number: Z-1168-2014.
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