Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spirit MB Bracket Recalled by Ormco/Sybronendo Due to Ormco Corporation initiated this recall of Spirit MB...
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
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.
Quantity: 150 units
Why Was This Recalled?
Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, 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, leading to movement 10 degrees in the wrong direction.
Where Was This Sold?
Internationally Distributed in the country of Japan.
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