Valorem Surgical LLC

Valorem Surgical LLC: 144 FDA recall reports

Every medical device recall the FDA has published for Valorem Surgical LLC. The fault, and how the agency graded it.

144Reports
0Class I
0Ongoing
2017-08-16Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II144
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Ch

Z-2958-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical,

Z-2925-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS Body Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgica

Z-3011-201  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
262 units total

PALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, I

Z-2957-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicag

Z-2895-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy

Z-2927-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 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 spine.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgica

Z-2880-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valo

Z-2943-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago,

Z-3015-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Guide Wire. 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
262 units total

PALLAS M/MAXIMIS MIS Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical

Z-2919-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago,

Z-2971-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
262 units total

PALLAS M/MAXIMIS MIS Pedicle Cut. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chi

Z-2981-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
262 units total

PALLAS M/MAXIMIS Poly Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgica

Z-2903-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 6.5 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS Poly Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgic

Z-2935-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS C. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, I

Z-3010-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS C. 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
262 units total

PALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener. Part of MAXIMIS Pedicle Screw Spinal Fixation System.

Z-2998-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
262 units total

PALLAS M/MAXIMIS MIS Poly Screw Driver B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgi

Z-2881-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical

Z-2917-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 6.5 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS 55mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicag

Z-2894-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS 60mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chi

Z-2875-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical

Z-2914-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgica

Z-2901-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS Ratchet T Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Ch

Z-3003-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
262 units total

PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgica

Z-2902-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS Dilator A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago,

Z-2979-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
262 units total

PALLAS M/MAXIMIS 35mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, I

Z-2955-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicag

Z-2886-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS 30mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, I

Z-2882-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

PALLAS M/MAXIMIS Rod Pusher B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicag

Z-3016-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent with Quality System Requirements.
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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
262 units total

PALLAS M/MAXIMIS 80mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicag

Z-2889-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Devices are not consistent 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.
Where it went
Nationwide Distribution - US including CA and VA.
How much
2,225 units total

Showing the 30 most recent of 144. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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