Z-2859-2026Class II

Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System

Name: Z-2859-2026 Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Creator: Innovasis, Inc
Published: 2026-05-22
License: https://open.fda.gov/license/

Innovasis, Inc / initiated 2026-05-22 / Open, Classified / root cause: manufacturing process

FDA source

Innovasis, Inc began a recall of Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System on 2026-05-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2859-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-22
Posted: 2026-08-03
Recalling firm: Innovasis, Inc
Product: Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 801-261-2242 Mon-Fri 8:00am - 5:00pm MST.
Quantity in commerce: 5
Distribution: US Nationwide distribution in the states of TX, CA.
Product codes and lots: LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2859-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2859-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03

Product code NKB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)