The Recall Desk
ModerateFDA (Devices)·Z-2886-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M/MAXIMIS 50mm MIS Rods for Quality Issues

Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 50mm MIS 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 involves a quality system deviation 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 50mm MIS 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 No. M058-050 and Known Lot No. WNV120322. The devices were distributed nationwide in the United States, including California and Virginia. The product was labeled as the Pallas M Spinal Fixation System through 2015.

This recall is classified as Class II by the FDA. Consumers and healthcare providers should contact Valorem Surgical for further information regarding the recall and potential replacement or refund options.

The recalled product

Product
PALLAS M/MAXIMIS 50mm MIS 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 Implant
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. M058-050
  • 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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