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

FDA device recall Z-0935-2014 · posted 2014-02-06 · Terminated

Recall details

Recalling firm

Zest Anchors LLC

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

Action taken

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".

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

DZE

Quantity affected

3,130

Distribution

Distributed in Ohio and Switzerland.

Date initiated

2014-01-16

Date posted

2014-02-06

Date terminated

2014-05-15

Location

Escondido, CA

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