Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
FDA Recall Z-2859-2026 · Posted 2026-08-03
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Recalling FirmInnovasis, Inc
Recall StatusOpen, Classified
Product CodeNKB
Date Initiated2026-05-22
Product Quantity5
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
US Nationwide distribution in the states of TX, CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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