FDAClass IIIMarch 6, 2013

Avex CX Suite recall

Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use…

Why was Avex CX Suite recalled?

Orthodontic brackets distributed was incorrectly labeled.

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?

Lot R131360

Product
Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use…
Recalling firm
Ultradent Products, Inc.
Quantity
124
Distribution
USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Recall date
March 6, 2013
Classification
Class III
Status
Terminated
Agency
FDA (device)
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