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

126–144 of 144

ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Extension Guide Bushes for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Guide Bushes because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Extension Guide Bush. 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
HighFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Polyaxial Spinal Screws
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS polyaxial screws due to quality system non-compliance. The devices are intended for spinal fixation.
Product
PALLAS M/MAXIMIS Polyaxial Screw and MIS Screw, 5.5 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 s
Category
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling Pallas M/MAXIMIS MIS Pedicle Screws because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 5.5 x 50mm and 5.5 x 5.0 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
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Inside Bender Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Inside Bender devices due to quality system non-compliance.
Product
PALLAS M/MAXIMIS Inside Bender (L) and (R). 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 Devices for Quality Issues
Valorem Surgical is recalling 262 Pallas M/MAXIMIS Anti Torque Devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Anti Torque Device. 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 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
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 50mm Straight Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 50mm Straight Rods because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 50mm 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 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 5.5 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-cervical spine.
Category
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Persuader Spinal Fixation Instruments
Valorem Surgical is recalling 262 Pallas M/MAXIMIS Persuader instruments because they do not meet FDA quality system requirements.
Product
PALLAS M/MAXIMIS Persuader. 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 35mm MIS Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 35mm MIS Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 35mm 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 Nut Drivers for Quality System Non-Compliance
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Nut Drivers because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. 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 Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS pedicle screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5 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 spi
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 Crosslink devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Crosslink 50-70mm. 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 Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 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
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 30 mm Curved Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 30 mm Curved Rods due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS 30 mm Curved 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 S. Spinal Fixation Probes
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS S. probes used in spinal fixation systems because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS S. Probe. 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 Spinal Fixation Rods
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 250mm Straight Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 250mm 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 Screw Fixation Components
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Reduction A components due to quality system non-compliance.
Product
PALLAS M/MAXIMIS Reduction A. 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 Marking Pins for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Marking Pins because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Marking Pin (Round Jaw). 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