CLASS III Device recall · Reported 31 Oct 2012 · FDA Enforcement Report
The name of the device is Damon 3MX Bicuspid Bracket recalled
Ormco/Sybronendo is recalling The name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket, distributed nationwide in the US. The recall was initiated on 24 Apr 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0120-2013
- FDA event ID
- 63296
- Recalling firm
- Ormco/Sybronendo, Glendora, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Apr 2012
- FDA classified
- 23 Oct 2012
- Reported
- 31 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 24 Apr 2012 | Recall initiated by company | |
| 23 Oct 2012 | Classified by FDA | +182 days |
| 31 Oct 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is The name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket recalled?
Yes. Ormco/Sybronendo recalled The name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket on 24 Apr 2012. The recall is Class III and its status is Terminated. Recall number Z-0120-2013.
Why was it recalled?
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.
Which lots are affected?
Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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