FDA Medical Device Recalls (openFDA)
Ormco/Sybronendo: The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
- Recall number
- Z-0120-2013
- Recalling firm
- Ormco/Sybronendo
- Product
- The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
- Status
- Terminated
- Initiated
- 2012-04-24
- Posted
- 2012-10-23
- Terminated
- 2012-12-12
- Reason
- The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots, which identified them as maxillary central incisor brackets.
- Root cause
- Labeling mix-ups
- Action
- Ormco/Sybronendo sent an Urgent Medical Device Recall letter via USPS 1~1 class mail, on April 24, 2012 to all consignees. Consignees were sent an updated customer notification via USPS lSI class mail on June 28, 2012. The letters identified the affected product, problem and actions to be taken. Consignees were instructed to complete the Acknowledgement/Return Form and to return any affected product in their inventory. Customers were instructed to contact Ormco Customer Care at 1-800-854-1741 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.
- Quantity
- 148
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada, China, Costa Rica, Ecuador, French Polynesia, India, Kuwait, Malaysia, Philippines, Singapore, South Korea, Thailand and UAE.
- Lot, serial or model codes
- Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJF
- Firm FEI
- 2016150
- Firm city
- Glendora
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28