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Terminated

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

FDA Recall Z-1169-2014 · Posted 2014-03-12

Recalling FirmBiomet 3i, LLC
Recall StatusTerminated
Product CodeLRO
Date Initiated2013-07-22
Date Terminated2015-04-21
Product Quantity541

Reason for Recall

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

Firm Action

Biomet 3i sent an Urgent Medical Device Field Correction Notice dated July 2013 to all affected customer via email, facsimile, or postal mail. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to complete the attached response form and fax to 561-514-6316. For questions contact Biomet 3i customer service at 1-800-342-5454.

Root Cause

Unknown/Undetermined by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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