Recall Z-1167-2018 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
SwishTapered Implant Intended for use in support for fixed bridgework.
| Date | Jan 19, 2018 |
| Status | Terminated |
| Reason | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer). |
| Root cause | Process control |
| Action | Customers were sent Urgent: Safety Alert/Advisory Notice letters around 01/19/2018. The Notice identified the affected device and the reason for the correction. Instructions for both distributors and doctors include to review inventory for affected product, complete and return the Acknowledgement form within 48 hours of receipt of the letter, follow the included instructions to correct the affected product, and distributors are to notify those customers that may have been shipped the affected product lot and inform them of the issue. Questions should be directed to Implant Direct Sybron Man |
| Quantity | 1,117 units total |
| Distribution | Worldwide Distribution -- US, Europe, Canada, Australia, and Japan. |
| 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 |