device · product 1 of 13
Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
- Recall number
- Z-1783-2018
- Initiated
- May 01, 2018
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- TP Orthodontics, Inc.
- Quantity
- 108
App-derived interpretation
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
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.
Code information
15915000, 17615000, 17715000, 18015000, 18115000, 18915000, 20315000, 23915000, 24515000, 25715000, 25815000, 26515000, 29415000, 29315000, 32915000
Distribution pattern
Distributed to accounts in 20 states: AL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, and VA. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Germany, Spain, Finland, France, Great Britain, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Portugal, Singapore, and South Africa.