LEONE SPA
LEONE SPA · Model G8010-16 · UDI-DI 08033707062172
DZD
Prescription
8
510(k) clearances
25
Adverse events
4
Recalls
114
Facilities
Description
TUBE MIM 22/18 BH R
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-17 | Ormco/Sybronendo | The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal |
| 2020-01-17 | Ormco/Sybronendo | The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal |
| 2013-03-08 | Ormco/Sybronendo | Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correct |
| 2010-11-01 | Ortho Organizers Inc | Products were mis-labeled as nickel free. |
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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.