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

Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment. — recall Z-0481-2014

U.S. FDA — Device Enforcement · United States · 2013-11-19 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0481-2014
Date of alert
2013-11-19
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Ultradent Products, Inc.
Product category
device
Product type
Devices
Reported risk: Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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