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Carriere® Motion Pro™

Ortho Organizers, Inc. · Model 425-827C · UDI-DI 00190707103095

DYWEJF Prescription
1
510(k) clearances
45
Adverse events
5
Recalls
27
Facilities

Description

Carriere® Motion Pro™ Clear Bite Corrector 27 mm 1-Set

Recalls

DateFirmReason
2014-03-25Ormco/SybronendoOrmco 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
2011-05-18Ormco CorporationOrmco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
2011-05-18Ormco CorporationOrmco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
2005-11-03Ormco CorporationTwo part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
2005-11-03Ormco CorporationTwo 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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Data 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.