FDA-Device2019-11-20Class II
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
Implant Direct Sybron Manufacturing, LLC
Hazard
A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
Sold states
U.S.: IN, VA, MD, TX, WA OUS: Japan
Affected count
23 implants
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
Products
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0364-2020Don't want to check this manually?
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