Recall Z-2551-2018 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
| Date | Mar 3, 2017 |
| Status | Terminated |
| Reason | The main vial label lists the incorrect part number, but the cap label is correct. |
| Root cause | Process control |
| Action | Recall notifications dated 2/13/2017 were issued to U.S. consignees via UPS overnight on 3/3/2017. Foreign consignees received letters on 3/13/2017 and 3/14/2017. |
| Quantity | 124 units |
| Distribution | Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM Implant Direct Sybron Manufacturing, LLC, Dec 24, 2013 |