Reported Apr 6, 2016 · Terminated

The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that…

Implant Direct Sybron Manufacturing, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Implant Direct Sybron Manufacturing, LLC · 3050 E Hillcrest Dr · Westlake Village, CA · 91362-3171

Is this the product you have?

  • 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
Lot codes and dates
  • Lot Number
    • 29707
    • 29708
    • 29709
    • 32444
    • 37438
    • 38159
    • 39506
    • 40394
    • 40542
    • 44661
    • 46030
    • 50644
    • 50824
    • 51092
    • 51249
    • 52798
    • 54274
    • 54275
    • 54617
    • 55407
    • 60158
Amount recalled
2033

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 17, 2016 · Data as of Sep 19, 6:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.