BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appl

FDA device recall Z-0750-2025 · posted 2024-12-23 · Open, Classified

Recall details

Recalling firm

Straight Smile, LLC

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.

Action taken

On 11/04/2024 and 11/07/2024, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via email to customers informing them of the potential risks associated with BYTE Aligners that the patient onboarding workflow may not provide adequate assurance that patients with active periodontal disease, severe open bite, severe overjet, tooth malocclusion requiring surgical correction, mixed dentition, dental prosthetics or dental implants, or adolescents with skeletally narrow jaws do not enter treatment with BYTE Aligners. The BYTE workflow may not be adequate to identify the conditions for which BYTE Aligners are contraindicated because an in-person exam is not performed. This means that potential patients with one of the above issues may not be appropriately filtered out from treatment. For customers who are actively in treatment. To minimize the risk of illness or injury, we recommend the following: For customers who knowingly suffer from active periodontal disease, severe open bite, severe overjet, tooth malocclusion requiring surgical correction, mixed dentition, have dental prosthetics or dental implants, or are an adolescent with a skeletally narrow jaw, discontinue aligner treatment immediately and visit a dental professional. For all other customers, please promptly visit a dental professional to confirm whether continuing aligner treatment is appropriate for you. Following your dentist visit, please visit https://patient.byte.com/support to upload (i) the name and contact information for the dental professional you visited, (ii) the date visited, and (iii) any visit notes provided by the dental professional during your visit. BYTE will reach out to you to gather a signed consent to enable us to gather other information needed from such dental professional. For questions/concerns - contact treating dentist by submitting a support request through Patient Account Center (https://patient.byte.com/support), the My Byte App, or calling Byte support (877) 298-36

Root cause

Device Design

Status

Open, Classified

Product code

NXC

Quantity affected

5,324,178 devices

Distribution

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, M

Date initiated

2024-11-04

Date posted

2024-12-23

Location

Lehi, UT

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