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Recall Observatory FDA recall evidence

Device product

SICAT IMPLANT V2.0

Z-2951-2020

July 15, 2020

Class II

Product summary

Firm
SICAT GMBH & CO. KG
Event
Event 86165
Status
Terminated
Classification
Class II
Quantity
853 units
Official record key
device-enforcement:Z-2951-2020

Official wording

Reason: A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.

Code information: V2.0

Distribution pattern: Worldwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.