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U.S. Department of Health and Human Services

Class 2 Device Recall Ormco Damon Q2 Orthodontic Metal Bracket

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  Class 2 Device Recall Ormco Damon Q2 Orthodontic Metal Bracket see related information
Date Initiated by Firm January 14, 2020
Create Date June 05, 2020
Recall Status1 Open3, Classified
Recall Number Z-2286-2020
Recall Event ID 85427
Product Classification Bracket, metal, orthodontic - Product Code EJF
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.
Code Information Lot number 031902599
Recalling Firm/
Manufacturer		 Ormco/Sybronendo
1332 S Lone Hill Ave
Glendora CA 91740-5339
For Additional Information Contact Ms. Valerie Cimmarusti
714-516-7476
Manufacturer Reason
for Recall		 The bracket torque was mislabeled on the packaging.
FDA Determined
Cause 2		 Process control
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: 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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