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

Recall Z-2129-2014 — Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.

U.S. FDA — Device Enforcement · United States · 2014-07-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2129-2014
Date of alert
2014-07-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Novocol, Inc.
Product category
device
Product type
Devices
Reported risk: Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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