FDA-Device2021-11-10Class II
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Implant Direct Sybron Manufacturing LLC
Hazard
Packaged dental implant contains a different size then the size declared on the labeling.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.
Affected count
83 implants
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
Products
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0198-2022Don't want to check this manually?
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