The Recall Desk
ModerateFDA (Devices)·Z-2876-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Crosslink Spinal Fixation Devices

Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Crosslink devices 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 does not report any hospitalizations, injuries, or illnesses, 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 Crosslink 50-70mm, which is part of the MAXIMIS Pedicle Screw Spinal Fixation System. These devices are intended for posterior pedicle screw fixation of the non-cervical spine. The product was distributed nationwide in the United States, including California and Virginia, and was labeled as the Pallas M Spinal Fixation System through 2015.

The recall was initiated because the devices are not consistent with Quality System Requirements. The specific catalog number for the affected units is CL060-100, while the lot number is unknown. No specific injuries, illnesses, or deaths are reported in the source text.

Healthcare providers and consumers should stop using these devices and contact Valorem Surgical LLC for further instructions on how to return or dispose of the product.

The recalled product

Product
PALLAS M/MAXIMIS Crosslink 50-70mm. 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
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. CL060-100
  • Lot No. Unknown.

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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