The Recall Desk
ModerateFDA (Devices)·Z-3012-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Driver Shaft for Quality System Non-Compliance

Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Driver Shafts because the devices 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. The source text cites non-compliance with Quality System Requirements but does not report any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary recall.

Plain-English summary

Valorem Surgical LLC is recalling 262 units of the PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. This instrument is part of the MAXIMIS Pedicle Screw Spinal Fixation System and is 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 specific lot number is WNV111014. The affected units were distributed nationwide in the United States, including California and Virginia.

Healthcare providers and consumers should stop using the affected driver shafts and contact Valorem Surgical LLC for instructions on how to return the product.

The recalled product

Product
PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. 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-cervic
Manufacturer
Valorem Surgical LLC
Category
Medical Device — Spinal Fixation Instrument
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)

  • Instrument
  • Known Lot No. WNV111014.

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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