The Recall Desk
HighFDA (Devices)·Z-2898-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk medical device (spinal fixation) where the specific hazard is a Quality System violation. Per the rubric, risk-of-harm products where injury has not yet been reported fall under the High severity category.

Plain-English summary

Valorem Surgical LLC is recalling 2,225 units of the Pallas M/MAXIMIS Poly Screw 5.5 x 30mm, part of the MAXIMIS Pedicle Screw Spinal Fixation System. The product, intended for posterior pedicle screw fixation of the non-cervical spine, was distributed nationwide in the United States, including California and Virginia. The specific catalog number is P355-030, and the known lot number is WNV120322.

The recall was initiated because the devices are not consistent with Quality System Requirements. This classification indicates a potential risk to patient safety, though the source text does not specify the exact nature of the quality defect or report any specific injuries or illnesses.

Healthcare providers and patients who have used or may have used these specific spinal fixation devices should contact Valorem Surgical LLC for further instructions on how to proceed. The recall is classified as Class II by the FDA.

The recalled product

Product
PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. 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
2,225

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. P355-030
  • Known Lot No. WNV120322

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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