Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in
FDA device recall Z-0481-2014 · posted 2013-12-11 · Terminated
Recall details
- Recalling firm
- Ultradent Products, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- NJM
- Quantity affected
- 217 units
- Distribution
- Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
- Date initiated
- 2013-11-19
- Date posted
- 2013-12-11
- Date terminated
- 2014-10-06
- Location
- South Jordan, UT
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