Recall Z-0935-2014— Zest Anchors LLC

Name: FDA recall Z-0935-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-16

Class II · Terminated

Class II FDA medical device recall by Zest Anchors LLC, initiated 2014-01-16, terminated 2014-05-15. It names 2 FDA 510(k) clearances: K072878, K994257. 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: 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.

Recalling firm: Zest Anchors LLC
Classification: Class II
Status: Terminated
Initiated: 2014-01-16
Terminated: 2014-05-15
Firm location: Escondido, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K072878 — MODIFICATION TO: LOCATOR IMPLANT ANCHORZest Anchors, Inc.·cleared 2007-12-03
K994257 — LOCATOR IMPLANT ANCHORZest Anchors, Inc.·cleared 2000-03-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.