Recall Record

Aliso Viejo, CA, United States

Orthalign, Inc recalls

1 recall recorded since 2018, most recently on 10 February 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
10 February 2026
Reason
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Distribution
US Nationwide distribution in the state of UT.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1629-2026, Z-1630-2026

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.