Reported Dec 18, 2013 · Terminated
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in…
Ultradent Products, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ultradent Products, Inc. · 505 W 10200 S · South Jordan, UT · 84095-3935
Is this the product you have?
- Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
- Lot codes and dates
- R&D Lot Numbers
4519 - 45224524 - 45274530 - 45344537 - 45484550 - 45544558 - 46124618 - 4624
- R&D Lot Numbers
- Amount recalled
- 217 units
Where it was sold
Why it was recalled
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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