Recall Z-1136-2012 ยท EJF Bracket, Metal, Orthodontic
Ormco Corporation
Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210. The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
| Date | Mar 1, 2012 (initiated Feb 13, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of -9. The packaging was labeled with +9 torque; however the brackets contained inside the packaging are actually Orthos CM Brackets with a torque of -9. |
| Root cause | Process control |
| Action | Ormco Corporation sent an Urgent Field Safety Notice dated February 13, 2009, to all affected customers. The recall communication for consignees in the United States, Canada, Colombia, HongKong, Kuwait, United Arab Emirates, Mexico, Russia, South Africa and Croatia was sent on February 13, 2009 via USPS First Class Mail. The recall communication for consignees in Japan was sent on February 17, 2009. European consignees were sent recall notification on February 23, 2009. The Australian consignees and New Zealand consignees were the sent recall communication on February 25, 2009. Customers we |
| Quantity | 304 units |
| Distribution | Worldwide Distribution - USA (nationwide) and worldwide to Canada, Colombia, Hong Kong, Kuwait, United Arab Emirates, Mexico, Russia, South Africa, Croatia, Japan, France, Bulgaria, Germany, Estonia, United Kingdom, Hungary, Ireland, Italy, Netherlands, Australia, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.