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.
FDA Recall Z-2286-2020 · Posted None
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Recalling FirmOrmco/Sybronendo
Recall StatusTerminated
Product CodeEJF
Date Initiated2020-01-14
Date Terminated2025-02-10
Product Quantity2,189 units
Reason for Recall
The bracket torque was mislabeled on the packaging.
Firm Action
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: [email protected] 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 [email protected] 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 [email protected].
Root Cause
Process control
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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