Innovasis, Inc.

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.

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

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

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

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

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

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.