FDA Device recall Z-0120-2013
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket
- FDA Device
- Class III
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class III recall of The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket by Ormco Sybronendo, citing 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 maxilla….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0120-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-04-24 |
| Published | 2012-10-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ormco Sybronendo |
| Distribution | US |
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.
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.
Identifiers
| code_info | Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0120-2013%22
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