Innovasis

6 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices, Implants & Prosthetics

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 are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA 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.

Class I - Dangerous

Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.

Aug 14, 2024 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

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.

Apr 7, 2020 Other Medical Devices Nationwide View Details →

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, lumbar, and sacral spine:

Class I - Dangerous

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

Jan 8, 2018 Other Medical Devices View Details →

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 used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.

Class I - Dangerous

Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).

May 5, 2017 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.

Dec 7, 2015 Implants & Prosthetics View Details →

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.

Class I - Dangerous

Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.

Jul 7, 2014 Implants & Prosthetics Nationwide View Details →