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Recall Observatory FDA recall evidence

Device product

ImplantDirect, Dental implants 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.

Z-2551-2018

March 03, 2017

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 79855
Status
Terminated
Classification
Class II
Quantity
124 units
Official record key
device-enforcement:Z-2551-2018

Official wording

Reason: The main vial label lists the incorrect part number, but the cap label is correct.

Code information: Lot #87837

Distribution pattern: Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label lists the incorrect