The Recall Desk
ModerateFDA (Devices)·Z-2964-2017·Announced 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.

What this means for you

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 cites a Quality System Requirement inconsistency without reporting specific injuries, illnesses, or high-risk pathogens, aligning with a moderate severity for a voluntary precautionary or quality-based recall.

Plain-English summary

Valorem Surgical LLC is recalling the Pallas M/MAXIMIS Wall Check, a component of the MAXIMIS Pedicle Screw Spinal Fixation System. The device is intended for posterior pedicle screw fixation of the non-cervical spine. The recall involves 262 units distributed nationwide, including California and Virginia.

The recall was initiated because the devices are not consistent with Quality System Requirements. The specific catalog number is 0703-0007, and the known lot number is WNV111115. The product was labeled as the Pallas M Spinal Fixation System through 2015.

Healthcare providers and facilities should stop using the affected devices and contact Valorem Surgical for further instructions. No specific injuries or illnesses have been reported in the source text.

The recalled product

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.
Manufacturer
Valorem Surgical LLC
Category
Medical Device — Orthopedic / Spinal Fixation
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 (2)

  • Catalog No. 0703-0007
  • Known Lot No. WNV111115.

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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