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U.S. Department of Health and Human Services

Class 2 Device Recall Vector Pedicle Screw System

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 Class 2 Device Recall Vector Pedicle Screw Systemsee related information
Date Initiated by FirmMay 22, 2026
Date PostedAugust 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2859-2026
Recall Event ID 99188
510(K)NumberK241276 K250182 K251073 
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
ProductAnti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Code Information LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
FEI Number 3004719693
Recalling Firm/
Manufacturer		 Innovasis, Inc
614 E 3900 S
Salt Lake City UT 84107-1902
Manufacturer 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.
FDA Determined
Cause 2		Process design
ActionOn 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 in Commerce5
DistributionUS Nationwide distribution in the states of TX, CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NKB
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