Recall record at a glance
| Official record | Z-0876-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Ultradent Products, Inc. |
| Report date | Mar 6, 2013 |
| Recall initiation date | Feb 8, 2013 |
| Quantity | 124 |
| Location | South Jordan, UT, United States |
Official product description
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.
Why the product was recalled
Orthodontic brackets distributed was incorrectly labeled.
Distribution information
USA Nationwide Distribution including the states of CA, AZ, CO and WA.
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.