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
Product summary
- 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
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.