Recall Z-0727-2018 ยท DZE Implant, Endosseous, Root-Form
Keystone Dental Inc
Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
| Date | Aug 25, 2017 |
| Status | Terminated |
| Reason | The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06. |
| Root cause | Error in labeling |
| Action | On August 18, 2017 a letter titled "Product Action S2400K, Stage-1 RDS Indexed Abutment, Lot 34276" was issued to customers requesting persons to review their inventory and respond if product has been used or not. A response form is requested from these customers with instruction to return any unused product. Questions or concerns can be directed to: Customer Relations: Toll Free 866-902-9272 |
| Quantity | 20 |
| Distribution | Nationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS Lifecore Biomedical, Inc., Oct 23, 2007 |