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

101–125 of 144

ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Body Alignment Drivers for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Body Alignment Drivers because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Body 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 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 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 Compressor and Rod Tightener
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS MISS/MIS Compressor and Rod Tighteners because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener. 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 80mm Straight Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 80mm Straight Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 80mm 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 Poly Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 6.5 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/MAXIMIS Dilator A Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Dilator A due to quality system non-compliance. The devices are used for spinal fixation.
Product
PALLAS M/MAXIMIS Dilator 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 Rod Pusher B Instruments
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Pusher B instruments due to quality system non-compliance. The devices are part of a spinal fixation system.
Product
PALLAS M/MAXIMIS Rod Pusher B. 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 30mm Spinal Fixation Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 30mm rods due to quality system non-compliance. The devices are distributed nationwide in the US.
Product
PALLAS M/MAXIMIS 30mm 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 80mm MIS Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 80mm MIS Rods due to inconsistencies with Quality System Requirements.
Product
PALLAS M/MAXIMIS 80mm 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 Pedicle Screws for Quality System 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 Polyaxial and MIS 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 Pedicle Screws for Quality Issues
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they do not meet FDA quality system requirements.
Product
PALLAS M/MAXIMIS Poly Screw 6.5 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/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 (Smooth). 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 Awl for Quality System Non-Compliance
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Awls because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Awl. 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 Head Holders for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Head Holders because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Head Holder. 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 Compressor for Quality System Non-Compliance
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Compressors because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Compressor. 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 Drivers 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 MISS/MIS 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 Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly 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-cervica
Category
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 60mm MIS Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 60mm MIS Rods due to non-compliance 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 Distractor for Quality System Non-Compliance
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Distractors because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Distractor. 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 Cut Devices for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS MIS Pedicle Cut devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Pedicle Cut. 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 Poly Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 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-cervical spine.
Category
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Large Crosslink Spinal Fixation Devices
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Large Crosslink devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Large 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 Curved Rods for Quality System Non-Compliance
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 5.5 x 05mm Curved Rods because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 5.5 x 05mm 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 55mm MIS Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 55mm MIS Rods because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 55mm 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 70mm Curved Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 70mm Curved Rods due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS 70mm 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