Ormco Recalls Titanium Orthos Brackets Due to Incorrect Color Marking
Ormco is recalling 150 units of Titanium Orthos Brackets because the color identification dot was marked on the wrong tie-wing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a cosmetic or documentation defect (incorrect color marking) with no reported injuries or health hazards, fitting the criteria for a Low severity score.
Plain-English summary
Ormco Corporation has initiated a recall of 150 units of U2R Titanium Orthos Brackets (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169. These orthodontic brackets are fixed attachments used to hold archwires during orthodontic treatment.
The recall was initiated because the color identification dot was marked on the wrong tie-wing of the brackets. The affected units were distributed in the United States and Canada.
The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these units.
The recalled product
- Product
- Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
- Manufacturer
- Ormco/Sybronendo
- Hazard
- Affected units
- 150
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 (2)
- Part Number 449-6212
- Lot Number 121359169.
Distribution
Distribution scope not specified by the agency.
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