Z-1330-2014 Class II Terminated
FDA device recall Z-1330-2014 was initiated by Ormco/Sybronendo on March 25, 2014 and is designated Class II. Reason for recall: 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 miside… The recall status is terminated (terminated April 18, 2014). Affected quantity: 150 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2014
- Initiation Date
- March 25, 2014
- Termination Date
- April 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Internationally Distributed in the country of Japan.
Code Information
Part Number 494-0110, Lot Number 081351013.