LEONE SPA
LEONE SPA · Model F7214-06 · UDI-DI 08033707055648
EJF
Prescription
10
510(k) clearances
148
Adverse events
8
Recalls
160
Facilities
Description
DB BRACKETS 44 MINI DIAG 22 T-17 BH
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-14 | Ormco/Sybronendo | The bracket torque was mislabeled on the packaging. |
| 2019-04-02 | Ortho Organizers, Inc. | Orthodontic Bracket is mislabeled |
| 2019-04-02 | Ortho Organizers, Inc. | Orthodontic Bracket is mislabeled |
| 2014-03-25 | Ormco/Sybronendo | Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of t |
| 2013-02-08 | Ultradent Products, Inc. | Orthodontic brackets distributed was incorrectly labeled. |
| 2012-04-24 | Ormco/Sybronendo | The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillar |
| 2009-02-13 | Ormco Corporation | The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of -9. The packaging w |
| 2004-11-18 | Ormco Corporation | Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed. |
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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.