Recall Z-2425-2020— Zest Anchors LLC

Name: FDA recall Z-2425-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-22

Class II · Ongoing

Class II FDA medical device recall by Zest Anchors LLC, initiated 2019-11-22. It names one FDA 510(k) clearance: K120198. Product: LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .. Reason: The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient..

Recalling firm: Zest Anchors LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-11-22
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K120198 — LOCATOR OVERDENTURE IMPLANT SYSTEMZest Anchors, LLC·cleared 2012-06-06

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 OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

Reason for recall

The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.

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