Innovasis Recalls
7 recalls on record · July 23, 2014 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 12, 2026Medical DevicesFDA
Innovasis, Inc recalls Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Hazard: 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.
September 25, 2024Medical DevicesFDA
Innovasis, Inc recalls TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fu
Hazard: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
May 27, 2020Medical DevicesFDA
Innovasis, Inc recalls Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical
Hazard: Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as "Fixed. If user installs a fixed rescue screw instead of variable, the screw head may not be flush, it could back out, which could interfere with the cover screw.
February 28, 2018Medical DevicesFDA
Innovasis, Inc recalls Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide
Hazard: Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
May 31, 2017Medical DevicesFDA
Innovasis, Inc recalls Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. P
Hazard: Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
January 27, 2016Medical DevicesFDA
Innovasis, Inc recalls 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 P
Hazard: Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
July 23, 2014Medical DevicesFDA
Innovasis, Inc recalls Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged i
Hazard: Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.