FDA-Device2017-05-31Class II

Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

Implant Direct Sybron Manufacturing, LLC
Hazard

Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.

Sold states
Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
Affected count
151 units
Manufactured in
3050 E Hillcrest Dr, Westlake Village, CA, United States
Products
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2125-2017

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