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Terminated

Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.

FDA Recall Z-0481-2014 · Posted 2013-12-11

Recalling FirmUltradent Products, Inc.
Recall StatusTerminated
Product CodeNJM
Date Initiated2013-11-19
Date Terminated2014-10-06
Product Quantity217 units

Reason for Recall

Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.

Firm Action

Ultradent Products notified consignees via email on November 19, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product. Sales representatives will pick up remaining unplaced brackets or returns will be sent back using pre-paid envelopes back to Ultradent recall coordinator for quarantine. Consignees were asked to complete evaluation forms to be returned by fax to 800-793-5206. For questions regarding this recall call 801-553-4420.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution including UT, CA, WA, VA, OH, and TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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