Recall Z-1789-2018— TP Orthodontics, Inc.
Class II · Terminated
Class II FDA medical device recall by TP Orthodontics, Inc., initiated 2018-05-01, terminated 2020-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.. Reason: The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient..
- Recalling firm
- TP Orthodontics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-01
- Terminated
- 2020-04-15
- Firm location
- La Porte, IN, United States
Product description
Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Reason for recall
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.