FDA-Device2016-04-06Class II
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
Implant Direct Sybron Manufacturing, LLC
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.
Sold states
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.
Affected count
2033
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2016Don't want to check this manually?
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