Innovasis, Inc recalls Anti-Torque

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.

On 5/22/2026, recall notices were emailed to distributors who were informed of the following: 1) Firm personnel will coordinate product replacement with customers. 2) Once all affected parts have been returned, a Product Removal Attestation Form will be sent to customers. This form must be filled in, signed and returned for regulatory purposes. If you have any questions, contact firm Customer Support at support@innovasis.com 801-261-2242 Mon-Fri 8:00am - 5:00pm MST.

• FDA enforcement recordOfficial FDA database entry for Z-2859-2026
• FDA 510(k) clearance · K241276The device's official FDA premarket clearance record
• FDA 510(k) clearance · K250182The device's official FDA premarket clearance record
• FDA 510(k) clearance · K251073The device's official FDA premarket clearance record
• FDA device classification · NKBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3070The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Innovasis, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.