The Recall Desk
ModerateFDA (Devices)·Z-2993-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Anti Torque Devices for Quality Issues

Valorem Surgical is recalling 262 Pallas M/MAXIMIS Anti Torque 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 does not report any illnesses, injuries, or hospitalizations, and the hazard is a quality system non-conformance rather than a specific physical defect causing harm.

Plain-English summary

Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Anti Torque Device, 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 recall was initiated because the devices are not consistent with Quality System Requirements.

The affected products are identified by Catalog No. 0902-1021 and known Lot Nos. WNV111108 and WNV120802. The devices were distributed nationwide in the United States, including California and Virginia. 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. The FDA has classified this as a Class II recall.

The recalled product

Product
PALLAS M/MAXIMIS Anti Torque Device. 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 — 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. 0902-1021. Known Lot No. WNV111108
  • WNV120802.

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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