The Recall Desk
ModerateFDA (Devices)·Z-3004-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M/MAXIMIS I Handle for Quality Issues

Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS I Handles because they do not meet FDA 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 due to non-compliance with Quality System Requirements, which typically falls under moderate severity for voluntary or administrative recalls without reported injuries.

Plain-English summary

Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS I Handle, 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 due to the devices not being consistent with Quality System Requirements.

The affected units were distributed nationwide in the United States, including California and Virginia. The specific catalog number is 0902-1037, and the known lot numbers are WNV111125, WNV120802, and WNV111109. The product was labeled as the Pallas M Spinal Fixation System through 2015.

Healthcare providers and patients should stop using the affected handles and contact Valorem Surgical LLC for further instructions. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
PALLAS M/MAXIMIS I Handle. 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
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 (3)

  • Catalog No. 0902-1037. Known Lot No. WNV111125
  • WNV120802
  • WNV111109.

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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