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 al
FDA device recall Z-0876-2013 · posted 2013-02-22 · Terminated
Recall details
- Recalling firm
- Ultradent Products, Inc.
- Reason for recall
- Orthodontic brackets distributed was incorrectly labeled.
- Action taken
- Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 8 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to return affected products for replacement. Customers with questions can call firm representative, Corey Jaseph at (801) 553-4220.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- EJF
- Quantity affected
- 124
- Distribution
- USA Nationwide Distribution including the states of CA, AZ, CO and WA.
- Date initiated
- 2013-02-08
- Date posted
- 2013-02-22
- Date terminated
- 2013-06-07
- Location
- South Jordan, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REFLECTIONS - CERAMIC DENTAL BRACKET (K922499) | Cdb Corp. | 1992-07-30 |