Recall Z-2859-2026 · NKB Thoracolumbosacral Pedicle Screw System
Innovasis, Inc
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
| Date | Aug 3, 2026 (initiated May 22, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 5 |
| Distribution | US Nationwide distribution in the states of TX, CA. |
| FDA record | Open on fda.gov |