Zest Anchors LLC recalls LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

Recall date

November 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2425-2020

FDA classification

Class II

Brand / firm

Zest Anchors LLC

Sold / distributed

US Nationwide Distribution in the state of: WI; VA; OH; IL; GA; NC; KS; NJ; CA; WA; OK; MO and Puerto Rico OUS: Switzerland, Germany, Mexico, Poland, and Thailand

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .