All Recalls

95,083 total recalls in our database

PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm and 6.5 x 4.5 screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: " Iliac/femoral anatomy that is suitable for access with the required introduction systems, " Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: " with a length of at least 20 mm, and " with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.

Cook Medical Incorporated

🏥 Medical Devices Class I - Dangerous

There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.

Mar 22, 2017 Diagnostic Equipment Nationwide View Details →

PALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS Extension Block. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS Set Screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS 50mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS 35mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS 500mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

Piston Syringe and Hypodermic Needle, 1 CC TB 25 G X 5/8, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

International Medsurg Connection

🏥 Medical Devices Class I - Dangerous

Insufficient documentation to support product sterility claims.

Jun 23, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS 70mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

Hypodermic Needle, 22 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

International Medsurg Connection

🏥 Medical Devices Class I - Dangerous

Insufficient documentation to support product sterility claims.

Jun 23, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS 120mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

International Medsurg Connection

🏥 Medical Devices Class I - Dangerous

Insufficient documentation to support product sterility claims.

Jun 23, 2017 Surgical Instruments Nationwide View Details →

Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

International Medsurg Connection

🏥 Medical Devices Class I - Dangerous

Insufficient documentation to support product sterility claims.

Jun 23, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS Compass. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS 45mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Valorem Surgical

🏥 Medical Devices Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →