Recall Z-0481-2014 ยท NJM Bracket, Ceramic, Orthodontic
Ultradent Products, Inc.
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
| Date | Dec 11, 2013 (initiated Nov 19, 2013) |
| Status | Terminated |
| Reason | Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution. |
| Root cause | Process control |
| Action | Ultradent Products notified consignees via email on November 19, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product. Sales representatives will pick up remaining unplaced brackets or returns will be sent back using pre-paid envelopes back to Ultradent recall coordinator for quarantine. Consignees were asked to complete evaluation forms to be returned by fax to 800-793-5206. For questions regarding this recall call 801-553-4420. |
| Quantity | 217 units |
| Distribution | Nationwide Distribution including UT, CA, WA, VA, OH, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.