Recall Z-1330-2014— Ormco/Sybronendo
Class II · Terminated
Class II FDA medical device recall by Ormco/Sybronendo, initiated 2014-03-25, terminated 2014-04-18. It names one FDA 510(k) clearance: K943245. 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.. 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..
- Recalling firm
- Ormco/Sybronendo
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-25
- Terminated
- 2014-04-18
- Firm location
- Glendora, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.