Recall Z-1920-2018 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
| Date | Nov 15, 2016 |
| Status | Terminated |
| Reason | The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled. |
| Root cause | Labeling mix-ups |
| Action | Letters dated 11/14/2016 were issued via FedEx overnight on 11/15/2016. |
| Quantity | 18 units |
| Distribution | Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution. |
| 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 |