FDA Medical Device Recalls (openFDA)
Innovasis, Inc: Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
- Recall number
- Z-2859-2026
- Recalling firm
- Innovasis, Inc
- Product
- Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
- Status
- Open, Classified
- Initiated
- 2026-05-22
- Posted
- 2026-08-03
- Terminated
- not on file
- Reason
- 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
- 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 support@innovasis.com 801-261-2242 Mon-Fri 8:00am - 5:00pm MST.
- Quantity
- 5
- Distribution
- US Nationwide distribution in the states of TX, CA.
- Lot, serial or model codes
- LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
- 510(k) numbers
- ["K241276","K250182","K251073"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3004719693
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28