Ormco Damon Q2 Orthodontic Metal Bracket recalled over labeling errors

Recall date

January 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ormco/Sybronendo recalls Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco…

Recall number

Z-2286-2020

FDA classification

Class II

Brand / firm

Ormco/Sybronendo

Sold / distributed

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,…

Why it was recalled

The bracket torque was mislabeled on the packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.