Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
The brand name of the device is Damon 3MX Bicuspid Bracket Recalled by Ormco/Sybronendo Due to The firm initiated the recall as a result...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ormco/Sybronendo directly.
Affected Products
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Quantity: 148
Why Was This Recalled?
The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots, which identified them as maxillary central incisor brackets.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ormco/Sybronendo
Ormco/Sybronendo has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report