Recall Z-1267-2016 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
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
| Date | Mar 4, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Implant Direct sent an Urgent: Medical Device Field Corrective Action letter dated March 4, 2016, to all affected customers. The letter states that Implant Direct will correct the issue and send the proper tool. The proper tool is included with the notification. The letter requests that customers complete and return the Acknowledgement and Recall Return Form within 48 hours. It customers are an authorized Implant Direct Sybron Manufacturing distributor it is requested that customers are identified and contact them to inform them of the issue within 48 hours of receiving the notification. D |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 Implant Direct, LLC, May 15, 2009 |