Hazard

Quality System Non Compliance recalls

178 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 178
Critical: 0
Severe: 0
Most recent: 2023-11-01

Of the 178 quality system non compliance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all quality system non compliance recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 178

ModerateFDA (Devices)·Z-2973-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3016-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2892-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 45mm MIS Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 45mm MIS Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 45mm 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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2902-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3003-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2881-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2890-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2964-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2948-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2878-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2931-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screw Spinal Fixation Devices
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because the devices are not consistent with 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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2962-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2974-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2960-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2952-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3009-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2905-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2901-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3012-2017·2017-08-16
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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2963-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2943-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2879-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2875-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3013-2017·2017-08-16
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2920-2017·2017-08-16
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…
Category
Medical Device
Distribution
Distributed nationwide