Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2425-2020 — LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

U.S. FDA — Device Enforcement · United States · 2019-11-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2425-2020
Date of alert
2019-11-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zest Anchors LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840481101496
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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