FDA Device

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.

Hazard

Devices are not consistent with Quality System Requirements.

What You Should Do

Remedy

Valorem Surgical sent an Urgent Medical Device Recall letter dated June 21, 2017, informing consignees of the product removal and instructing consignees to return any product to Valorem Surgical LLC to minimize potential risk to patients. Consignees are to fill out the attached Medical Device Recall Return Response form and send it back to the firm by email at global.safety@ValoremSurgical.com or by fax at 312-275-7117, or by mail. For questions pertaining to this recall, please submit an email inquiry to global.safety@ValoremSurgical.com

Products

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
Brand
Valorem Surgical LLC
UPC
Catalog No. 0902-1007. Unknown Lot No.

Units Affected

2,225 units total