Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit M
FDA device recall Z-0201-2012 · posted 2011-11-16 · Terminated
Recall details
- Recalling firm
- Ormco Corporation
- Reason for recall
- Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
- Action taken
- 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 fax to 909-962-5605.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DYW
- Quantity affected
- 135 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 Afri
- Date initiated
- 2011-05-18
- Date posted
- 2011-11-16
- Date terminated
- 2012-04-24
- Location
- Glendora, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPIRIT MB (K943245) | Sybron Dental Specialties, Inc. | 1994-08-23 |