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Zest Anchors LLC recalls LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Recalled July 1, 2020 · FDA recall Z-2425-2020 · Zest Anchors
Hazard
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. · FDA Class II
Units
154 kits
Sold at
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
Description
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.
Product
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Manufacturer(s)
Zest Anchors LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →