The Recall Desk
ModerateFDA (Devices)·Z-2956-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Spinal Fixation Rods for Quality Issues

Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 300mm Straight Rods 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, and the source text does not report any injuries or illnesses, fitting the criteria for a moderate severity recall involving quality system non-compliance without reported harm.

Plain-English summary

Valorem Surgical LLC is recalling 2,225 units of the PALLAS M/MAXIMIS 300mm Straight Rod, 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 in the United States, including California and Virginia. The specific catalog number is SR60-300, and the known lot number is NHS160219.

The recall was initiated because the devices are not consistent with Quality System Requirements. This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients who have used this product should contact Valorem Surgical for further information. The source text does not report any specific injuries or illnesses associated with this recall.

The recalled product

Product
PALLAS M/MAXIMIS 300mm Straight Rod. 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. SR60-300
  • Known Lot No. NHS160219.

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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