Manufacturer

Valorem Surgical LLC

144 recalls in our database name Valorem Surgical LLC as the manufacturing or recalling firm.

What the numbers show

Total: 144
Critical: 0
Severe: 0
Most recent: 2017-08-16

Of the 144 recalls from Valorem Surgical LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 144

ModerateFDA (Devices)·Z-2978-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Dilator Handles for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Dilator Handles because they are not consistent with Quality System Requirements. The devices are part of a spinal fixation system.
Product
PALLAS M/MAXIMIS Dilator 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2902-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2941-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 5.5 x 40mm and 5.5 x 4.0 mm screw. 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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2964-2017·2017-08-16
Valorem Surgical Recalls Pallas M Wall Check Spinal Fixation Devices
Valorem Surgical LLC is recalling Pallas M/MAXIMIS Wall Check devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Wall Check. 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2968-2017·2017-08-16
Valorem Surgical Recalls Pallas M Anti Torque Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Anti Torque devices due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS Anti Torque. 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2944-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 60mm Spinal Fixation Rods
Valorem Surgical LLC is recalling 2,225 units of Pallas M/MAXIMIS 60mm curved and precontoured rods due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS 60mm Curved and Precontoured 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2956-2017·2017-08-16
Valorem Surgical Recalls Pallas M Spinal Fixation Rods for Quality Issues
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 300mm Straight Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 300mm 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2921-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 7.5 x 50mm pedicle screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS 7.5 x 50mm screw. 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2923-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 5.5 x 45mm & 5.5 x 4.0mm, and 7.5 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-c
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2873-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Instrument Taps for Quality Issues
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 5.5 mm Instrument Taps because they are not consistent with Quality System Requirements.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2877-2017·2017-08-16
Valorem Surgical Recalls Pallas M Crosslink Spinal Fixation Devices
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Small Crosslink devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Small 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2984-2017·2017-08-16
Valorem Surgical Recalls Pallas M Spinal Fixation Extensions
Valorem Surgical is recalling 262 Pallas M/MAXIMIS Open Extension (Small) devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Open Extension (Small). 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3002-2017·2017-08-16
Valorem Surgical Recalls Pallas M Torque Handles for Quality System Issues
Valorem Surgical is recalling 262 Pallas M/MAXIMIS Torque Handles because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Torque 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3000-2017·2017-08-16
Valorem Surgical Recalls Pallas M Rod Checker and T-Bar Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Rod Checker and T-Bar devices due to quality system non-compliance.
Product
PALLAS M/MAXIMIS Rod Checker and T-Bar. 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2943-2017·2017-08-16
Valorem Surgical Recalls Pallas M Spinal Fixation Rods
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 50mm spinal fixation rods due to quality system non-compliance. The devices are distributed nationwide in the US.
Product
PALLAS M/MAXIMIS 50mm Curved and precontoured 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2926-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3015-2017·2017-08-16
Valorem Surgical Recalls Pallas M Guide Wires for Quality System Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Guide Wires because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Guide Wire. 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2917-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with FDA Quality System Requirements.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2893-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 50mm MIS Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 50mm MIS Rods because they are not consistent with Quality System Requirements.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2904-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screws for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 7.5 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2907-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 7.5 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2966-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Nut Drivers for Quality Issues
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Nut Drivers because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Nut Driver 4.0 Hexa and Alignment Driver. 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 sp
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2887-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 60mm MIS Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 60mm MIS Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 60mm 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3001-2017·2017-08-16
Valorem Surgical Recalls Pallas M Rod Pusher for Quality System Issues
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Rod Pusher Angled because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Rod Pusher Angled. 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2957-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 40mm Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 40mm Rods because they are not consistent with Quality System Requirements.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide