The Recall Desk
ModerateFDA (Devices)·Z-2971-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Distractor for Quality System Non-Compliance

Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Distractors 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, and the source text cites non-compliance with Quality System Requirements without reporting specific injuries, illnesses, or deaths, aligning with the criteria for moderate severity.

Plain-English summary

Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Distractor, which is part of the MAXIMIS Pedicle Screw Spinal Fixation System. The device is intended for posterior pedicle screw fixation of the non-cervical spine. The product was distributed nationwide in the United States, including California and Virginia.

The recall was initiated because the devices are not consistent with Quality System Requirements. The specific catalog number is 0703-0017, and the known lot number is WNV100630. The product was labeled as the Pallas M Spinal Fixation System through 2015.

Healthcare providers and patients who have used or possess this device should contact Valorem Surgical LLC for further instructions on how to proceed with the recall.

The recalled product

Product
PALLAS M/MAXIMIS Distractor. 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. 0703-0017
  • Known Lot No. WNV100630.

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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