CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report

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

Innovasis is recalling Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System, distributed nationwide in the US. The recall was initiated on 22 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014

Quantity recalled5

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2859-2026
FDA event ID: 99188
Recalling firm: Innovasis, Salt Lake City, UT
Classification: Class II
Status: Ongoing
Recall initiated: 22 May 2026
FDA classified: 3 Aug 2026
Reported: 12 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

22 May 2026	Recall initiated by company
3 Aug 2026	Classified by FDA	+73 days
12 Aug 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of TX, CA.

Nationwide California Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014

Where was it sold?

US Nationwide distribution in the states of TX, CA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Innovasis

All 7

Reported	Class	Recall	Company	Reason	Where
25 Sep 2024Device	CLASS II	TxHA PEEK IBF/TxTiHA IBF System recalled by Innovasis	Innovasis	Other	Nationwide
27 May 2020Device	CLASS II	Oryx Cervical Screw Caddy recalled by Innovasis	Innovasis	Device Malfunction	Nationwide
28 Feb 2018Device	CLASS II	Excella II Polyaxial Pedicle Screw used as a pedicle screw recalled	Innovasis	Device Malfunction	UT
31 May 2017Device	CLASS II	Opteryx Variable Rescue Screw, Part #CP2214 recalled by Innovasis	Innovasis	Foreign Material	Nationwide
27 Jan 2016Device	CLASS II	Excella II Rod recalled by Innovasis	Innovasis	Packaging Defects	4 states

Other Spinal Implants recalls

All 1,159

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide