Ormco Damon Q2 Orthodontic Metal Bracket recall: Labeling Error
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…
Why was Ormco Damon Q2 Orthodontic Metal Bracket recalled?
The bracket torque was mislabeled on the packaging.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number 031902599
- 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…
- Recalling firm
- Ormco/Sybronendo
- Quantity
- 2,189 units
- Distribution
- 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.
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)