Damon Q2 Orthodontic Bracket (Ormco) - Torque Mislabeling (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 been completed.
Brand
Ormco/Sybronendo
Lot Codes / Batch Numbers
Lot number 031902599
Products Sold
Lot number 031902599
Ormco/Sybronendo is recalling Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Ma due to The bracket torque was mislabeled on the packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The bracket torque was mislabeled on the packaging.
Recommended Action
Per FDA guidance
The firm, Ormco, sent "URGENT: MEDICAL DEVICE CORRECTION" letters dated 1/6/2020 via USPS on 1/14/2020 to consignees explaining the brackets were mislabeled and the risk associated with using the incorrect bracket. The consignees were requested to call Ormco customer service at 1-800-854-1741 or email: ormcocustcare@kavokerr.com to log any complaints related to this issue; assess your patients; over-label the affected product in inventory using the enclosed corrected label and complete the enclosed acknowledgement form and email the form to ormcocustcare@kavokerr.com within 10 business days. If you have any questions or require additional information, please contact our customer care department at 800-854-1741, between the hours of 7am to 5pm (PST) or send an email to ormcocustcare@kavokerr.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026