Device 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.
Z-1330-2014
Product summary
- Firm
- Ormco/Sybronendo
- Event
- Event 67849
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 units
- Official record key
device-enforcement:Z-1330-2014
Official wording
Reason: 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.
Code information: Part Number 494-0110, Lot Number 081351013.
Distribution pattern: Internationally Distributed in the country of Japan.
Derived failure modes
-
Unknown
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.