FDA-Device2016-09-28Class II
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Biomet 3i, LLC
Hazard
Product was incorrectly packaged.
Sold states
US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
Affected count
92 units
Manufactured in
4555 Riverside Dr, Palm Beach Gardens, FL, United States
Products
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2845-2016Don't want to check this manually?
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