Device Recall MAXIMIS Pedicle Screw Spinal Fixation System

Catalog No. 0703-0012; Known Lot No. WNV101203, WNV111130.

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

PALLAS M/MAXIMIS Rod Holder. 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. SR60-350; Known Lot No. NHS160219.

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

PALLAS M/MAXIMIS 350 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.

Catalog No. SR60-400; Known Lot No. NHS160219.

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

PALLAS M/MAXIMIS 400mm 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.

Catalog No. SR60-500; Known Lot No. NHS160219.

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

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.

Catalog No. 0703-0001; Known Lot No. WNV101126.

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

PALLAS M/MAXIMIS Awl. 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.