Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave proce

FDA device recall Z-1167-2014 · posted 2014-03-12 · Terminated

Recall details

Recalling firm

Biomet 3i, LLC

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LRO

Quantity affected

21

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,

Date initiated

2013-07-22

Date posted

2014-03-12

Date terminated

2015-04-21

Location

Palm Beach Gardens, FL