FDAMarch 3, 2017device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

implant direct sybron manufacturingimplantimplant direct

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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