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Recall Observatory FDA recall evidence

Device product

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

Z-2125-2017

May 02, 2017

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 77171
Status
Terminated
Classification
Class II
Quantity
151 units
Official record key
device-enforcement:Z-2125-2017

Official wording

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

Code information: 89103, 83493, 78986

Distribution pattern: Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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