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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

PALLAS M/MAXIMIS MIS Pedicle Cut. 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

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 55mm. 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

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 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS C. Probe. 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener. 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS MIS Poly Screw Driver 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

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 55mm. 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS 55mm 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS 60mm Curved 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

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 40mm. 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

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 45mm. 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS Ratchet T 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

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 27 G X 0.5, 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

Class I - Dangerous

Insufficient documentation to support product sterility claims.

Jun 23, 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 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

Class I - Dangerous

Insufficient documentation to support product sterility claims.

Jun 23, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS Dilator A. 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS 35mm 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

PALLAS M/MAXIMIS 50mm 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Sorin Group USA

Class I - Dangerous

Identification of excess plastic on the tip of the cannula.

Jun 9, 2017 Other Medical Devices Nationwide View Details →

PALLAS M/MAXIMIS 30mm 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

Class I - Dangerous

Devices are not consistent with Quality System Requirements.

Jun 21, 2017 Surgical Instruments Nationwide View Details →