- Recalling firm
- Innovasis, Inc
- Reason for recall
- Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.
- Affected products (lot / model / serial)
- LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
- Units affected
- 5
- Distribution pattern
- US Nationwide distribution in the states of TX, CA.
- Firm location
- Salt Lake City, UT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2859-2026
- Recall initiated
- May 22, 2026
- FDA classification date
- August 3, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99188
- Last updated on HTM Vibe
- August 18, 2026