Drug recall
Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An…
FDA recall event 67849 · Class II · Ormco/Sybronendo
Key facts
| Event ID | 67849 |
|---|---|
| Recall numbers | Z-1330-2014 |
| Recalling firm | Ormco/Sybronendo |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 25, 2014 |
| Report date | Apr 9, 2014 |
| Termination date | Apr 18, 2014 |
| City | Glendora |
| State | CA |
| Country | United States |
| FEI number | 2016150 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: