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LEONE SPA

LEONE SPA · Model A1763-02 · UDI-DI 08033707001539

ECO Prescription
7
510(k) clearances
7
Adverse events
13
Recalls
82
Facilities

Description

MEMORIA SPRINGS 200 g FOR FAST BACK .

Recalls

DateFirmReason
2018-05-01TP Orthodontics, Inc.The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
2018-05-01TP Orthodontics, Inc.The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
2018-05-01TP Orthodontics, Inc.The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
2018-05-01TP Orthodontics, Inc.The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
2018-05-01TP Orthodontics, Inc.The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
2018-05-01TP Orthodontics, Inc.The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
2018-05-01TP Orthodontics, Inc.The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
2018-05-01TP Orthodontics, Inc.The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
2018-05-01TP Orthodontics, Inc.The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
2018-05-01TP Orthodontics, Inc.The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.

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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.