Recall Z-0010-2020 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
| Date | Aug 7, 2018 |
| Status | Terminated |
| Reason | The incorrect device was packaged in the vial. |
| Root cause | Employee error |
| Action | The recalling firm issued letters dated 8/7/2018 via FedEx or email on 8/7/2018 informing the consignee of the issue and requesting they review their inventory for the affected product and quarantine it until it is returned. |
| Quantity | 158 devices |
| Distribution | Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061319 | SPECTRA SYSTEM Implant Direct, LLC, Sep 29, 2006 |