Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0935-2014 — 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

U.S. FDA — Device Enforcement · United States · 2014-01-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0935-2014
Date of alert
2014-01-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zest Anchors LLC
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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