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Flexmedics · Model 45-L3-8RK-V · UDI-DI 10195291002707
DYW
Prescription
1
510(k) clearances
45
Adverse events
5
Recalls
27
Facilities
Description
Composite Twin ROTH .018 LR3 HK -11°T +5°A 2°R 5PK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-03-25 | Ormco/Sybronendo | 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 m |
| 2011-05-18 | Ormco Corporation | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. |
| 2011-05-18 | Ormco Corporation | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. |
| 2005-11-03 | Ormco Corporation | Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. |
| 2005-11-03 | Ormco Corporation | Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.