The Recall Desk
ModerateFDA (Devices)·Z-2883-2017·Announced 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.

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 only Quality System non-compliance without reporting specific injuries, illnesses, or structural failures, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Valorem Surgical LLC is recalling 2,225 units of the Pallas M/MAXIMIS 35mm MIS rod, which is part of the MAXIMIS Pedicle Screw Spinal Fixation System. The product is intended for posterior pedicle screw fixation of the non-cervical spine. The recall is being conducted because the devices are not consistent with Quality System Requirements.

The affected products were distributed nationwide in the United States, including California and Virginia. The specific catalog number is M058-035. Known lot numbers include WNV110428, though some units may have unknown lot numbers. The product was labeled as the Pallas M Spinal Fixation System through 2015.

Healthcare providers and patients should check their inventory and medical records for this specific device. If the device is found, it should be removed from use and returned to Valorem Surgical LLC according to the company's instructions.

The recalled product

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.
Manufacturer
Valorem Surgical LLC
Category
Medical Device — Orthopedic / Spinal Fixation
Hazard
Affected units
2,225

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. M058-035
  • Known Lot No. WNV110428 & Unknown.

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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