The Recall Desk

Manufacturer

Innovasis, Inc

7 recalls in our database name Innovasis, Inc as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2026-08-12

Of the 7 recalls from Innovasis, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • HighFDA (Devices)·Z-2859-2026·2026-08-12

    Anti-Torque Instrument in Vector Pedicle Screw System Recalled

    Innovasis, Inc is recalling 5 Anti-Torque instruments (part LS-749) in the Vector Pedicle Screw System due to an undersized condition that may prevent proper engagement during spinal surgery, causing delays.

    Product
    Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3163-2024·2024-09-25

    Innovasis spinal fusion devices recalled for implant-inserter interface defect

    Innovasis is recalling TxHA PEEK and TxTiHA IBF intervertebral fusion devices due to interfacing issues between the implant and inserter that may prevent proper placement. The recall affects 568 devices distributed nationwide.

    Product
    TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2020·2020-05-27

    Innovasis Recalls Oryx Cervical Screw Caddies Due to Incorrect Labeling

    Innovasis is recalling six Oryx Cervical Screw Caddies because the labels for fixed and variable rescue screws are swapped. This mislabeling could lead to improper screw installation.

    Product
    Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0644-2018·2018-02-28

    Innovasis Recalls Nine Lots of 8.5 mm Polyaxial Pedicle Screws

    Innovasis, Inc. is recalling nine lots of 8.5 mm Polyaxial Pedicle Screws due to a risk of breakage. The recall covers 1,010 parts distributed in the United States.

    Product
    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumba
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2153-2017·2017-05-31

    Innovasis Recalls Opteryx Variable Rescue Screws with Incorrect Size Engraving

    Innovasis, Inc. is recalling 21 Opteryx Variable Rescue Screws because they are engraved with an incorrect, larger size (16 instead of 14).

    Product
    Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0662-2016·2016-01-27

    Innovasis Recalls Excella II Titanium Spine Rods Due to Labeling Error

    Innovasis is recalling two lots of Excella II titanium spine rods because they were packaged with each other's labels.

    Product
    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 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2067-2014·2014-07-23

    Innovasis Recalls Excella II Pedicle Screws Due to Mislabeling

    Innovasis is recalling 32 units of Excella II Standard Pedicle Screws because the size and catalog number are mislabeled.

    Product
    Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Innovasis, Inc.

Source: Wikidata (Q140345630), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.