The Recall Desk
ModerateFDA (Devices)·Z-2962-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Tapper Spinal Fixation Devices

Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Tapper 5.5 spinal fixation devices due to quality system non-compliance.

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 cites only non-compliance with Quality System Requirements without reporting specific injuries, illnesses, or structural defects, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Tapper 5.5, 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 is being conducted because the devices are not consistent with Quality System Requirements.

The affected products were distributed nationwide in the United States, including California and Virginia. The specific catalog number is 0703-0004, and the known lot number is WNV111130. 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 LLC for further instructions regarding the recall.

The recalled product

Product
PALLAS M/MAXIMIS Tapper 5.5. 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
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. 0703-0004
  • Known Lot No. WNV111130.

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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