Data Foundry

Medical device recalls 2026

Anti-Torque — Class II medical device recall Z-2859-2026

Ongoing recall by Innovasis, Inc, reported 2026-08-12, distributed nationwide. Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoraci

Recall numberZ-2859-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmInnovasis, Inc, Salt Lake City, UT, United States
Recall initiated2026-05-22
Classified2026-08-03
Reported by FDA2026-08-12
DistributedNationwide (US)
Quantity5
Serial numbers002, 003, 007, 012, 014
Model numbersLS-749

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2859-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.