FDAFDA · Food and drugs·Recall number Z-2286-2020
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.
Published June 17, 2020 · Recall initiated: January 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The bracket torque was mislabeled on the packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ormco/Sybronendo
- Distributor
- 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.
- Lot
- Lot number 031902599
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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