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

1–25 of 144

ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling 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 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
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS MIS Tapper 5.5mm Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MIS Tapper 5.5mm because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Tapper 5.5mm. 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 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
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M Tapper Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Tapper 5.5 spinal fixation devices due to quality system non-compliance.
Product
PALLAS M/MAXIMIS Tapper 5.5. 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 50mm Curved Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 50mm Curved Rods because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS 50mm 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 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 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 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
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS MIS Tapper 6.5mm Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS MIS Tapper 6.5mm devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Tapper 6.5mm. 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 Closed Extension Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Closed Extension devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Closed Extension. 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 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 5.5 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/MAXIMIS 35mm Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 35mm Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 35mm 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 Holder for Quality System Non-Compliance
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Holders because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Rod 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
HighFDA (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 FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. 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 MAXIMIS Pedicle Screws for Quality System Non-Compliance
Valorem Surgical LLC is recalling 2,225 units of MAXIMIS Pedicle Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw5.5 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 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 MIS Alignment Drivers
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS MIS Alignment Drivers because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS 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 Tapper for Quality System Non-Compliance
Valorem Surgical LLC is recalling Pallas M/MAXIMIS Tapper 6.5 devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Tapper 6.5. 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 MIS Pedicle Screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm and 6.5 x 4.5 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 sp
Category
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 50mm MIS Rods for Quality Issues
Valorem Surgical 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 45mm Straight Rods
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 45mm Straight Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 45mm 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/MAXIMIS 120mm MIS Rods for Quality Issues
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 120mm MIS Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 120mm 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 Checkers for Quality System Defects
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Checkers because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Rod Checker. 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 350 Straight Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 350 Straight Rods because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 350 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/MAXIMIS 400mm Straight Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 400mm Straight Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 400mm 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