FDA (Devices) recall action 77500

Valorem Surgical LLC recalled 144 products on 2017-08-16

The FDA (Devices) publishes a recall like this one as 144 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 144 pages.

Products: 144
Announced: 2017-08-16
Critical: 0
Units: 210,210

Why these products were recalled

Devices are not consistent with Quality System Requirements.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

26–50 of 144

ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screw Extensions for Quality Issues
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Open Extensions because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Open Extension (Large). 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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Poly Screw Driver for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Poly Screw Drivers because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 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 spine.
Category
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
HighFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Set Screws for Quality System Non-Compliance
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Set Screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS Set 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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Rod Gauges for Quality Issues
Valorem Surgical is recalling 262 Pallas M/MAXIMIS Rod Gauges because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Rod Gauge. 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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states