Recall Z-0200-2012 ยท DYW Bracket, Plastic, Orthodontic
Ormco Corporation
Spirit MB Brackets, part #494-1210. The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.
| Date | Nov 16, 2011 (initiated May 18, 2011) |
| Status | Terminated |
| Reason | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. |
| Root cause | Device Design |
| Action | Ormco Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product. If any of the affected product is found, customers are directed to contact Ormco Customer Care at 1-800-854-1741 to receive a RMA number. The RMA number will allow a quick return and replacement or credit. Additionally, a Recall Return/ Acknowledgement Form was attached for customers to complete and return via f |
| Quantity | 10 packs |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943245 | SPIRIT MB Sybron Dental Specialties, Inc., Aug 23, 1994 |