CLASS III Device recall · Reported 6 Mar 2013 · FDA Enforcement Report
Avex CX Suite, Avex CX 0.22 UL4,5 HK recalled by Ultradent Products
Ultradent Products is recalling Avex CX Suite, Avex CX 0.22 UL4,5 HK, distributed nationwide in the US. The recall was initiated on 8 Feb 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0876-2013
- FDA event ID
- 64303
- Recalling firm
- Ultradent Products, South Jordan, UT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Feb 2013
- FDA classified
- 22 Feb 2013
- Reported
- 6 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 8 Feb 2013 | Recall initiated by company | |
| 22 Feb 2013 | Classified by FDA | +14 days |
| 6 Mar 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Orthodontic brackets distributed was incorrectly labeled.
Product as listed by the FDA
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 of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
Where it was distributed
USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Questions about this recall
Why was it recalled?
Orthodontic brackets distributed was incorrectly labeled.
Which lots are affected?
Lot R131360
Where was it sold?
USA Nationwide Distribution including the states of CA, AZ, CO and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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