Recall Z-2286-2020 ยท EJF Bracket, Metal, Orthodontic
Ormco/Sybronendo
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
| Date | Jan 14, 2020 |
| Status | Terminated |
| Reason | The bracket torque was mislabeled on the packaging. |
| Root cause | Process control |
| Action | The firm, Ormco, sent "URGENT: MEDICAL DEVICE CORRECTION" letters dated 1/6/2020 via USPS on 1/14/2020 to consignees explaining the brackets were mislabeled and the risk associated with using the incorrect bracket. The consignees were requested to call Ormco customer service at 1-800-854-1741 or email: ormcocustcare@kavokerr.com to log any complaints related to this issue; assess your patients; over-label the affected product in inventory using the enclosed corrected label and complete the enclosed acknowledgement form and email the form to ormcocustcare@kavokerr.com within 10 business days. |
| Quantity | 2,189 units |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AR, AZ, FL, GA, IL, LA, MS, NC, NE, NJ, NY, PA, TN, and TX. Foreign distribution was made to Belgium, Czech Republic, France, Germany, Israel, Italy, Kuwait, Latvia, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, South Africa, Spain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.