Jasper Vektor, Class II Correction Appliance, Part No. 610-533 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.

Code information: 16015000, 17415000, 17515000, 17715000, 18815000, 25815000, 26515000, 30715000, 30815000, 31515000, 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.