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Recall Observatory FDA recall evidence

Device product

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

Z-1267-2016

March 04, 2016

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 73448
Status
Terminated
Classification
Class II
Quantity
2033
Official record key
device-enforcement:Z-1267-2016

Official wording

Reason: 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.

Code information: Lot Number: 29707, 29708, 29709, 32444, 37438, 38159, 39506, 40394, 40542, 44661, 46030, 50644, 50824, 51092, 51249, 52798, 54274, 54275, 54617, 55407,60158

Distribution pattern: Worldwide Distribution - Nationwide Distribution to the states of : FL, AZ, IL, MS, TX, CA, ID, AL, MO, MN, NY, CO, GA, ME, NJ, NC, NV, LA, KS, MN, KY, PA, UT, OH, MI, SC, MD, WA, WI., and to the countries of : Canada, Honduras and Dominican Republic.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.