Recall Z-2286-2020— Ormco/Sybronendo
Class II · Terminated
Class II FDA medical device recall by Ormco/Sybronendo, initiated 2020-01-14, terminated 2025-02-10. FDA's recall record names no specific 510(k) clearance for this event. 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: The bracket torque was mislabeled on the packaging..
- Recalling firm
- Ormco/Sybronendo
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-14
- Terminated
- 2025-02-10
- Firm location
- Glendora, CA, United States
Product 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 for recall
The bracket torque was mislabeled on the packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.