FDA Enforcement
Class II
Terminated
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.
Recall: Z-2286-2020
·
Reported June 17, 2020
Enforcement
- Recall Number
- Z-2286-2020
- Event ID
- 85427
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ormco/Sybronendo
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 17, 2020
- Initiation Date
- January 14, 2020
- Classification Date
- June 5, 2020
- Termination Date
- February 10, 2025
- Address
- 1332 S Lone Hill Ave, N/A, Glendora, CA, 91740-5339, United States
Description
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
The bracket torque was mislabeled on the packaging.
Code Info
Lot number 031902599
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.
Quantity
2,189 units