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LEONE SPA

LEONE SPA · Model C5950-920 · UDI-DI 08033707005025

DZC Prescription

510(k) clearances

328

Adverse events

Recalls

171

Facilities

Description

ARCHES MEMORIA 20 MEDIUM LOWER

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.