The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2981-2017·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a quality system non-conformance rather than a direct physical defect causing harm.

Plain-English summary

Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MIS Pedicle Cut, which is part of the MAXIMIS Pedicle Screw Spinal Fixation System. The devices are intended for posterior pedicle screw fixation of the non-cervical spine. The product was labeled as the Pallas M Spinal Fixation System through 2015.

The recall was initiated because the devices are not consistent with Quality System Requirements. The affected units are identified by Catalog No. 0902-1005 and known Lot Nos. WNV120320 and WNV110826.

The devices were distributed nationwide in the United States, including California and Virginia. The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with the use of these devices.

The recalled product

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.
Manufacturer
Valorem Surgical LLC
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
262

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Catalog No. 0902-1005
  • Known Lot No. WNV120320
  • WNV110826.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 144 recalled by Valorem Surgical LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 144 products in this recall →

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