Recall Z-0639-2012 ยท DZC Wire, Orthodontic
Ormco Corporation
TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment.
| Date | Jan 11, 2012 (initiated Mar 15, 2011) |
| Status | Terminated |
| Reason | The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007. |
| Root cause | Packaging |
| Action | Ormco Corporation sent a Urgent Medical Device Recall letter dated April 29, 2011, to the customers in the United States and Canada via USPS First Class mail. The recall letter for customers in Europe are being translated. Ormco Corporation sent the recall letter dated May 20, 2011, to the customers in Austrailia. The letter identified the product the problem and the action needed to be taken by the customer. As a result of this situation the customer is instructed to return the affected lot number of product. This will be replaced at no charge or credited to account. Please label your |
| Quantity | 23 Packs |
| Distribution | Worldwide Distribution -- USA including the states of Indiana and Minnesota; and the countries of Canada, Europe and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.