LEONE SPA
LEONE SPA · Model A3620-13 · UDI-DI 08033707082378
5
510(k) clearances
86
Adverse events
6
Recalls
119
Facilities
Description
BABY RPE EXPANDER 4 ARMS 13mm .
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-07 | Brius Technologies Inc. | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |
| 2022-02-07 | Brius Technologies Inc. | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |
| 2022-02-07 | Brius Technologies Inc. | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |
| 2014-02-24 | Allesee Orthodontic Appliances | The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar |
| 2013-06-06 | Sybron Dental Specialties | The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Meta |
| 2009-10-02 | Ormco Corporation | Manufacturing Error: There is a potential for a braze joint failure in the upper telescopic rod assembly. Although an incident could occur in which the eyelet loses connection fro |
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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.