LOCATOR¿ Implant Attachment System — Class II medical device recall Z-0935-2014
Terminated recall by Zest Anchors LLC, reported 2014-02-12, distributed in OH. Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR¿ Implant Attachment Systems because it is
| Recall number | Z-0935-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zest Anchors LLC, Escondido, CA, United States |
| Recall initiated | 2014-01-16 |
| Classified | 2014-02-06 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-05-15 |
| Distributed | OH |
| Countries outside the US | CH |
| Quantity | 3,130 |
| Reason classes | labeling |
| Lot numbers | 10055, 10892, 10893, 11052, 11093, 11963, 12025, 12258, 12259, 12703, 12941, 13364, 13530, 14151, 14152, 14568, 15000, 15001, 15306, 15307, 15624, 17676, 18934, 19735, 19832, 20043, 20665, 20666, 21351, 22170, 22440, 25026, 25027, 25294, 25567, I0JQ7, I0K7X, I0K7Y, I0K7Z, I0KY7 and 2 more |
| Model numbers | 08877-SPI, 08877-SPI-TMS, 08878-SPI, 08878-SPI-TMS, 08879-SPI, 08880-SPI, 8875-SPI, 8875-SPI-TMS, 8876-SPI, 8876-SPI-TMS |
Product
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0935-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.