LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

Reason: Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR¿ Implant Attachment Systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 N-cm. It was recently noted by Zest that in order to provide an optimal performance by increasing the factor of safety between the failure load of the abutment screw and the recommend

Code information: Part Numbers: 8875-SPI, 8875-SPI-TMS, 8876-SPI, 8876-SPI-TMS, 08877-SPI, 08877-SPI-TMS, 08878-SPI, 08878-SPI-TMS, 08879-SPI, 08880-SPI; Lot Numbers: 11052, 15306, 20665, 21351, 12025,12259, 22440, I0K7X, I0K7Y, 11963,15307,17676,18934, 25294, 25567, I0JQ7, 12258,12941,15000, 19735, 20666, I0K7Z, I0KY7, 12703, 14568, 19832, 22170, I0LCG, 11093, 13364, 14151, 15624, 20043, 25026, 13530, I0LE4, 10055, 14152, 15001, 25027, 10892, 10893. Since the LOCATOR¿ Implant Attachment System (including the restorative components) is not sold by the Zest Anchors as a sterilized product, it does not have a designated shelf-life.

Distribution pattern: Distributed in Ohio and Switzerland.