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

51–75 of 144

ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 500mm Straight Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 500mm Straight Rods due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS 500mm 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 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/MAXIMIS 80mm Curved Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 80mm Curved Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 80mm 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 40mm Straight Rods for Quality Issues
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 40mm Straight Rods because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS 40mm 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 Extension Sleeves for Quality System Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Sleeves because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Extension Sleeve. 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 Straight Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 60mm Straight Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 60mm 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 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 5.5 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 45mm MIS pedicle screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 45mm MIS . 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
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 35mm MIS rods due to quality system non-compliance. The devices are used for spinal fixation.
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 Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 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 Set Screw Starter Instruments
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Set Screw Starters because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Set Screw Starter. 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 I Handle for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS I Handles because they do not meet FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS I 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/MAXIMIS MIS Anti Torque Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS MIS Anti Torque devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS 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/MAXIMIS 70mm MIS Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 70mm MIS Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 70mm 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 Cross Link Torque Handles
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Cross Link Torque Handles because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Cross Link 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 35mm Curved Rods for Quality Issues
Valorem Surgical is recalling 2,225 Pallas M 35mm Curved Rods because they do not meet FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS 35mm 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 Ratchet T Handle for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Ratchet T Handles because they do not meet FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS Ratchet T 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 Pedicle Screws for Quality Issues
Valorem Surgical 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 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 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 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 MIS Poly Screw Driver B
Valorem Surgical LLC is recalling 2,225 units of the Pallas M/MAXIMIS MIS Poly Screw Driver B because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Poly Screw Driver 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 60mm Curved Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 60mm Curved Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 60mm 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 Driver Shaft for Quality System Non-Compliance
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Driver Shafts because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. 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-cervic
Category
Distribution
2 states
ModerateFDA (Devices)··2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 40mm MIS Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 40mm MIS rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 40mm 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 Curved Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 5.5 x 35mm Curved Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 5.5 x 35mm 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 Spinal Fixation Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 70mm Straight Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 70mm 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