Device Recall MAXIMIS Pedicle Screw Spinal Fixation System

Catalog No. CL60-100; Known Lot No. NHS160219.

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

PALLAS M/MAXIMIS Large Crosslink. 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.

Catalog No. CR60-030; Lot No. Unknown.

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

PALLAS M/MAXIMIS 5.5 x 05mm 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.

Catalog No. C060-050; Known Lot No. WNV110516

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

PALLAS M/MAXIMIS 50mm 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.

Catalog No. C060-060; Known Lot No. WNV110516

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

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.

Catalog No. 0902-1007. Unknown Lot No.

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

PALLAS M/MAXIMIS 5.5 mm Instrument Tap. 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.