Z-0120-2013Class III

The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491...

Name: Z-0120-2013 The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491...
Creator: Ormco/Sybronendo
Published: 2012-04-24
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2012-04-24 / Terminated / root cause: labeling and UDI

FDA source

Ormco/Sybronendo began a recall of 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 -... on 2012-04-24. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0120-2013
Classification: Class III
Status: Terminated
Initiated: 2012-04-24
Posted: 2012-10-23
Terminated: 2012-12-12
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.
Product code: EJF Bracket, Metal, Orthodontic
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0120-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0120-2013	Class III	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-23

Product code EJF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)