Ormco Recalls Spirit MB Orthodontic Brackets Due to Misplaced ID Dot
Ormco/Sybronendo is recalling 150 Spirit MB Orthodontic Brackets because a misplaced ID dot may cause incorrect tooth placement.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (orthodontic bracket) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Ormco/Sybronendo is recalling 150 units of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013. These orthodontic brackets are fixed attachments used to hold archwires during treatment. The recall was initiated because the ID dot, which designates the bracket as distal/gingival, is misplaced.
The misidentification may lead an orthodontist to place the bracket on the wrong tooth. This error could result in the tooth moving 10 degrees in the wrong direction. The affected units were distributed internationally in Japan.
Consumers and healthcare providers should contact Ormco/Sybronendo for further instructions regarding the recall and proper handling of the affected brackets.
The recalled product
- Product
- Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
- Manufacturer
- Ormco/Sybronendo
- Category
- Medical Device — Orthodontic
- 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 494-0110
- Lot Number 081351013.
Distribution
Distribution scope not specified by the agency.
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