Food, drugs, devices › Innovasis, Inc
Device recall: Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Innovasis, Inc (Salt Lake City, UT) initiated this device recall on 22 May 2026; FDA lists 1 product record under event 99188, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Innovasis, Inc has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Innovasis, Inc, Salt Lake City, UT.
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."
Distribution
"US Nationwide distribution in the states of TX, CA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2859-2026 | Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System | 5 | Class II | Ongoing | 12 Aug 2026 |
Context
Other enforcement events for Innovasis, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Aug 2024 | TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion | Device | Class II | 1 |
| 7 Apr 2020 | Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical | Device | Class II | 1 |
| 8 Jan 2018 | Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide | Device | Class II | 1 |
| 5 May 2017 | Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Produ | Device | Class II | 1 |
| 7 Dec 2015 | Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Pack | Device | Class II | 1 |
| 7 Jul 2014 | Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in | Device | Class II | 1 |
All 7 events for Innovasis, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of TX, CA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.