FDA (Devices) recall action 79739
The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling five Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling 119 Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling 7 Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling 108 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling 126 Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling 7 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling 5 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling 10 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.