Ormco Recalls Damon 3MX Bicuspid Brackets Due to Misidentification
Ormco/Sybronendo is recalling 148 Damon 3MX Bicuspid Brackets because they were produced with incorrect dark blue ID dots instead of purple, leading to misidentification as maxillary central incisor brackets.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a labeling/identification error without reported injuries.
Plain-English summary
Ormco/Sybronendo is recalling 148 units of the Damon 3MX Bicuspid Bracket, Part Number 494-4491, Lot Number 011265039. The recall was initiated because the affected lot was produced with dark blue colored ID dots, which identify maxillary central incisor brackets, rather than the correct purple colored ID dots used for maxillary bicuspid brackets.
These orthodontic brackets are intended to be a fixed attachment on a tooth that holds an archwire during orthodontic treatment. The misidentification could lead to the incorrect placement of the device during treatment.
The affected product was distributed worldwide, including the United States, Canada, China, Costa Rica, Ecuador, French Polynesia, India, Kuwait, Malaysia, Philippines, Singapore, South Korea, Thailand, and the UAE. Consumers and healthcare providers should stop using the affected brackets and contact the manufacturer for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Ormco/Sybronendo
- Category
- Medical Device — Orthodontic
- Hazard
- Affected units
- 148
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part Number 494-4491
- Description -Damon 3MX Bicuspid Bracket
- Lot Number - 011265039
Distribution
Distributed nationwide across the United States.
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