Opal Orthodontics by Ultradent. Avex CX2 Ceramic recall
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Why was Opal Orthodontics by Ultradent. Avex CX2 Ceramic recalled?
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624
- Product
- Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
- Recalling firm
- Ultradent Products, Inc.
- Quantity
- 217 units
- Distribution
- Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
- Recall date
- December 18, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)