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
Reported: April 6, 2016 Initiated: March 4, 2016 #Z-1267-2016
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing, LLC
- Units Affected
- 2033
- Distribution
- 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.
- Location
- Westlake Village, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 2033.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2016. Severity: Moderate. Recall number: Z-1267-2016.
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