Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1267-2016 — 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

U.S. FDA — Device Enforcement · United States · 2016-03-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1267-2016
Date of alert
2016-03-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Implant Direct Sybron Manufacturing, LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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