Ormco Damon Q2 Orthodontic Metal Bracket — Class II medical device recall Z-2286-2020
Terminated recall by Ormco/Sybronendo, reported 2020-06-17, distributed nationwide. The bracket torque was mislabeled on the packaging.
| Recall number | Z-2286-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ormco/Sybronendo, Glendora, CA, United States |
| Recall initiated | 2020-01-14 |
| Classified | 2020-06-05 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2025-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, CH, CZ, DE, ES, FR, GB, IL, IT, KW, LB, LV, NO, PL, PT, SA, SK, TN, ZA |
| Quantity | 2,189 units |
| Reason classes | labeling |
| Lot numbers | 031902599 |
| Model numbers | 491-9834, L3R |
Product
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Reason for recall
The bracket torque was mislabeled on the packaging.
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-2286-2020. 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.