Recall record at a glance
| Official record | Z-0481-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Ultradent Products, Inc. |
| Report date | Dec 18, 2013 |
| Recall initiation date | Nov 19, 2013 |
| Quantity | 217 units |
| Location | South Jordan, UT, United States |
Official product description
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Why the product 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.
Distribution information
Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.