FDAMarch 4, 2016device

The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710

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

The hazard

Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level.

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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