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Ormco/Sybronendo Recall: Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R

Ormco/Sybronendo Recall: Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Ormco/Sybronendo; Product: Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Co

Recalling firmOrmco/Sybronendo
ProductOrmco 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 recallThe bracket torque was mislabeled on the packaging.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide 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,
Recall initiated20200114
Recall numberZ-2286-2020
Categorydevice
StateCA
CountryUnited States

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