Z-0935-2014Class II

LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient...

Name: Z-0935-2014 LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient...
Creator: Zest Anchors LLC
Published: 2014-01-16
License: https://open.fda.gov/license/

Zest Anchors LLC / initiated 2014-01-16 / Terminated / root cause: labeling and UDI

FDA source

Zest Anchors LLC began a recall of LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR... on 2014-01-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0935-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-16
Posted: 2014-02-06
Terminated: 2014-05-15
Recalling firm: Zest Anchors LLC
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
Product code: DZE Implant, Endosseous, Root-Form
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
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: Zest Anchors, LLC initiated this recall by sending customers recall notification letter on 01/16/2014 via FedEx overnight. The customer notification letter, titled, "IMPORTANT: MEDICAL DEVICE VOLUNTARY RECALL NOTICE", informed customers of the recall, reason for voluntary recall, product information with part numbers and lot numbers, actions to be taken, and contact information. The customer notification letter was accompanied by a response form titled "MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement & Receipt Form".
Quantity in commerce: 3,130
Distribution: Distributed in Ohio and Switzerland.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0935-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0935-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-06

Product code DZE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)