- Recalling firm
- Orthalign, Inc
- Reason for recall
- Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
- Affected products (lot / model / serial)
- Lot # 25091103BB/ UDI: 00810832032427
- Units affected
- 7 units
- Distribution pattern
- US Nationwide distribution in the state of UT.
- Firm location
- Aliso Viejo, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1629-2026
- Recall initiated
- February 10, 2026
- FDA classification date
- March 24, 2026
- FDA report date
- April 1, 2026
- FDA event ID
- 98516
- Last updated on HTM Vibe
- July 24, 2026