Straight Smile, LLC: Device Recall
Recall #Z-0750-2025 · 11/04/2024
Recall Details
- Recall Number
- Z-0750-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Straight Smile, LLC
- Status
- Ongoing
- Date Initiated
- 11/04/2024
- Location
- Lehi, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,324,178 devices
Reason for Recall
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
Product Description
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of CO, KS, MI, IL, GA NY, MN, IN, PA, TX, NJ, MS, RI, SD, FL, KY, CA, OR, WI, WY, MA, NC, WA, AR, UT, OH, SC, NM, CT, TN, LA, NE, AL, MO, VA, MD, IA, OK, NV, DE, VT, AZ, RI, HI, WV, NH, MT, AK, ID, Puerto Rico, ME and the countries of Australia.