The Recall Desk
ModerateFDA (Devices)·Z-2905-2017·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 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 explicitly states the issue is non-compliance with Quality System Requirements without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Valorem Surgical LLC is recalling 2,225 units of the PALLAS M/MAXIMIS Poly Screw 7.5 x 45mm, 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 and was distributed nationwide, including in California and Virginia. The specific catalog number is P375-045, and the known lot number is WNV120328.

The recall was initiated because the devices are not consistent with Quality System Requirements. The source text does not report any specific injuries, illnesses, or deaths associated with the use of these devices. The product was labeled as the Pallas M Spinal Fixation System through 2015.

Healthcare providers and facilities that have received these devices should stop using them and contact Valorem Surgical LLC for further instructions on the recall process.

The recalled product

Product
PALLAS M/MAXIMIS Poly Screw 7.5 x 45mm. 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. P375-045
  • Known Lot No. WNV120328.

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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