Recall Z-2425-2020 ยท DZE Implant, Endosseous, Root-Form
Zest Anchors LLC
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
| Date | Nov 22, 2019 |
| Status | Open, Classified |
| Reason | The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient. |
| Root cause | Process control |
| Action | The firm initially contacted their customers by phone between 11/20-22/2019 and then sent out Customer Notification Letters on 11/22/2019 via email. The Customer Notification Letter is informing customers: The firm has determined that the abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient. The potential gap between the implant and the abutment could result in a space for bacteria to potentially harbor and grow, which could lead to an increase in future infection risk. T |
| Quantity | 154 kits |
| Distribution | US Nationwide Distribution in the state of: WI; VA; OH; IL; GA; NC; KS; NJ; CA; WA; OK; MO and Puerto Rico OUS: Switzerland, Germany, Mexico, Poland, and Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120198 | LOCATOR OVERDENTURE IMPLANT SYSTEM Zest Anchors, LLC, Jun 6, 2012 |