The Recall Desk
ModerateFDA (Devices)·Z-2940-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M 35mm Curved Rods for Quality Issues

Valorem Surgical is recalling 2,225 Pallas M 35mm Curved Rods because they do not meet FDA 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 cites non-compliance with Quality System Requirements without reporting specific 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 35mm Curved 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. The recall is being conducted because the devices are not consistent with Quality System Requirements.

The affected products are identified by Catalog Numbers R060-035 and R060-040, with a known Lot Number of WNV120322. The products were distributed nationwide in the United States, including California and Virginia. 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 for further instructions. Consumers should not use these medical devices and should contact their healthcare provider if they have questions regarding the recall.

The recalled product

Product
PALLAS M/MAXIMIS 35mm Curved 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 — 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. R060-035 and R060-040
  • 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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