Recall Z-0018-2020 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants
| Date | Aug 8, 2018 |
| Status | Terminated |
| Reason | Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number. |
| Root cause | Employee error |
| Action | Recall letters dated 8/8/2018 were issued on 8/8/2018 via FedEx overnight mail to the U.S. and Canadian consignees and via email to the UAE consignee. |
| Quantity | 22 vials |
| Distribution | Worldwide distribution - US Nationwide including the states of CO, HI, ID, KS, NC, OH, OR, PA, SC, TN, and UT, and countries of Canada and the United Arab Emirates. |
| 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 |