The brand name of the device is Damon 3MX Bicuspid Bracket — Class III medical device recall Z-0120-2013
Terminated recall by Ormco/Sybronendo, reported 2012-10-31, distributed nationwide. The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets
| Recall number | Z-0120-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ormco/Sybronendo, Glendora, CA, United States |
| Recall initiated | 2012-04-24 |
| Classified | 2012-10-23 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2012-12-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CN, CR, EC, IN, KR, KW, MY, PH, SG, TH |
| Quantity | 148 |
| Lot numbers | 011265039 |
| Model numbers | 494-4491 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0120-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.