The Recall Desk
ModerateFDA (Devices)·Z-2954-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M/MAXIMIS Spinal Fixation Rods

Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 250mm Straight Rods 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 does not report any hospitalizations, injuries, or deaths, and the hazard is a quality system inconsistency rather than a specific physical defect causing harm.

Plain-English summary

Valorem Surgical LLC is recalling 2,225 units of the PALLAS M/MAXIMIS 250mm Straight 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 and was distributed nationwide in the US, including California and Virginia. The specific catalog number is S060-250, and the known lot number is WNV111123.

The recall was initiated because the devices are not consistent with Quality System Requirements. The source text does not report any specific illnesses, injuries, or deaths associated with these devices.

Healthcare providers and patients should check their inventory and records for the affected catalog and lot numbers. If the product is found, it should be removed from use and returned to Valorem Surgical LLC in accordance with the recall instructions.

The recalled product

Product
PALLAS M/MAXIMIS 250mm 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.
Manufacturer
Valorem Surgical LLC
Category
Medical Device — Orthopedic / Spinal
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. S060-250
  • Known Lot No. WNV111123.

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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