medical Class II Updated 2020-06-17

Ormco/Sybronendo recalls Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834,

Recalled 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.


Hazard / Issue

The bracket torque was mislabeled on the packaging.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot number 031902599
View official government recall

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