FDAClass IIFebruary 12, 2014

LOCATOR¿ Implant Attachment System. The LOCATOR¿ recall

LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The…

Why was LOCATOR¿ Implant Attachment System. The LOCATOR¿ recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The…
Recalling firm
Zest Anchors LLC
Quantity
3,130
Distribution
Distributed in Ohio and Switzerland.
Recall date
February 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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