Valorem Surgical LLC: Medical Device Recall in 2017 - (Recall #: Z-2957-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

PALLAS M/MAXIMIS 40mm 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.

Product Classification:

Class II

Date Initiated: June 21, 2017

Date Posted: August 16, 2017

Recall Number: Z-2957-2017

Event ID: 77500

Reason for Recall:

Devices are not consistent with Quality System Requirements.

Status: Terminated

Product Quantity: 2,225 units total

Code Information:

Catalog No. SR60-040; Known Lot No. WNV120328, WNV101022.

Distribution Pattern:

Nationwide Distribution - US including CA and VA.

Voluntary or Mandated:

Voluntary: Firm initiated