The Recall Desk
ModerateFDA (Devices)·Z-2903-2017·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 and is due to non-compliance with Quality System Requirements without reported 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 Poly Screw 6.5 x 55mm. This product is part of the MAXIMIS Pedicle Screw Spinal Fixation System and is intended for posterior pedicle screw fixation of the non-cervical spine. The specific units involved are identified by Catalog No. P365-055 and Lot No. WNV120322.

The recall was initiated because the devices are not consistent with Quality System Requirements. The affected 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 LLC 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 Poly Screw 6.5 x 55mm. 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. P365-055
  • 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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