# FDA recall Z-2286-2020

> **Ormco/Sybronendo** · Class II · device recall initiated 2020-01-14.

## 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.

## Distribution

Worldwide Distribution: US (nationwide) to states of: AR, AZ, FL, GA, IL, LA, MS, NC, NE, NJ, NY, PA, TN, and TX.  Foreign distribution was made to Belgium, Czech Republic, France, Germany, Israel, Italy, Kuwait, Latvia, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland,  Tunisia, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-2286-2020
- **Recalling firm:** Ormco/Sybronendo
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-14
- **Report date:** 2020-06-17
- **Termination date:** 2025-02-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glendora, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2286-2020

## Citation

> AI Analytics. FDA recall Z-2286-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2286-2020. Source: US FDA. Licensed CC0.

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