Recall Z-1786-2018 ยท ECO Spring, Orthodontic
TP Orthodontics, Inc.
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.
| Date | May 1, 2018 |
| Status | Terminated |
| Reason | The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient. |
| Root cause | Device Design |
| Action | On May 3, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter advised customers that the firm was voluntarily recalling Generation 1 Jasper Vektor Class 2 Correction Appliances due to receiving 106 customer complaints that the device had broken in the patient's mouth during placement and usage. Customers were instructed to do the following: 1. Locate any of the affected lots identified in the table below and quarantine the product. 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or refund, following the instructions below |
| Quantity | 119 |
| Distribution | 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, Netherla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.