FDA Device recall Z-1330-2014
Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013
- FDA Device
- Class II
- terminated
- Published 2014-04-09
On 2014-04-09 the FDA classified a Class II recall of Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013 by Ormco Sybronendo, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1330-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-25 |
| Published | 2014-04-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ormco Sybronendo |
| Distribution | n/a |
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.
Identifiers
| code_info | Part Number 494-0110, Lot Number 081351013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1330-2014%22
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