FDA-Device2017-12-06Class II
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Hazard
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
Sold states
Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.
Affected count
75 units
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
Products
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0185-2018Don't want to check this manually?
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