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.
What this means for you
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.
Related recalls
Same manufacturer · Ormco/Sybronendo
See all →- ModerateOrmco Damon Q2 Orthodontic Bracket Recalled for Packaging Labeling Error
FDA (Devices) · 2020-06-17
- ModerateOrmco SnapLink Brackets Recalled for Slide Door Failure
FDA (Devices) · 2020-02-26
- ModerateOrmco/Sybronendo Recalls SnapLink Brackets Due to Slide Door Failure
FDA (Devices) · 2020-02-26
- HighOrmco/Sybronendo Recalls Elements Obturation Units and Buchanan Heat Pluggers
FDA (Devices) · 2018-02-07
- ModerateSybronEndo Recalls Sealapex Xpress Root Canal Resin Due to Labeling Error
FDA (Devices) · 2016-09-28
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02