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Q.C.M.Retainer Wire

CHIKAMI MILTEC INC. · Model RWS-W50 · UDI-DI 04570077940302

DZC

510(k) clearances

328

Adverse events

Recalls

171

Facilities

Description

This product can be used to make a very aesthetic retainer called Q C M Retainer W The best feature of this product is that the resin part and the wire part are connected by screws so if the resin part gets dirty or damaged, the resin part can be replaced.

Recalls

Date	Firm	Reason
2015-11-04	Ormco/Sybronendo	Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
2013-12-13	Highland Metals, Inc.	Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark
2013-12-13	Highland Metals, Inc.	Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark
2011-03-15	Ormco Corporation	The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007.

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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.