Recall Z-0007-2018 ยท NHA Abutment, Implant, Dental, Endosseous
Implant Direct Sybron Manufacturing, LLC
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
| Date | Jul 21, 2017 |
| Status | Terminated |
| Reason | The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component. |
| Root cause | Employee error |
| Action | Recall notification letters were sent to consignees, via mail on 07/21/2107. Instructions included to review current inventory and remove affected product, to complete and return the Acknowledgement and Recall Return form, and to notify customers who received product if it was further distributed. |
| Quantity | 50 units |
| Distribution | Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT. |
| 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 |