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Recall Observatory FDA recall evidence

Device product

GoDirect Screw-Retaining Top Part Numbers: 4500-61

Z-0961-2017

November 28, 2016

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 75838
Status
Terminated
Classification
Class II
Quantity
14
Official record key
device-enforcement:Z-0961-2017

Official wording

Reason: Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

Code information: Lot #75808

Distribution pattern: U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.