Ormco Damon Q2 Orthodontic Bracket Recalled for Packaging Labeling Error
Ormco/Sybronendo is recalling 2,189 units of Damon Q2 Orthodontic Metal Brackets because the bracket torque was mislabeled on the packaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a packaging labeling error regarding torque specifications without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Ormco/Sybronendo is recalling 2,189 units of Ormco Damon Q2 Orthodontic Metal Brackets, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. The recall is due to a labeling error where the bracket torque was mislabeled on the packaging.
The affected product is Lot number 031902599. The device is intended for the temporary orthodontic movement of teeth and is removed after treatment is completed. The recall covers units distributed nationwide in the United States to the states of AR, AZ, FL, GA, IL, LA, MS, NC, NE, NJ, NY, PA, TN, and TX, as well as to various foreign countries including Belgium, the Czech Republic, France, Germany, Israel, Italy, Kuwait, Latvia, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland, Tunisia, the United Arab Emirates, and the United Kingdom.
Consumers and healthcare providers should contact Ormco/Sybronendo for further instructions regarding the return or replacement of the affected brackets.
The recalled product
- 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 bee
- Manufacturer
- Ormco/Sybronendo
- Category
- Medical Device — Orthodontic
- Hazard
- Affected units
- 2,189
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 031902599
Distribution
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