The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2949-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M/MAXIMIS 45mm Straight Rods

Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 45mm Straight Rods because they are not consistent with Quality System Requirements.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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. The source text cites non-compliance with Quality System Requirements but does not report any illnesses, injuries, or specific safety hazards, 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 45mm 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. The recall is being conducted because the devices are not consistent with Quality System Requirements.

The affected product is identified by Catalog No. S060-045 and Known Lot No. WNV101015. The product was labeled as the Pallas M Spinal Fixation System through 2015. The recall number is Z-2949-2017.

The devices were distributed nationwide in the US, including California and Virginia. No specific instructions for consumers or healthcare providers are provided in the source text.

The recalled product

Product
PALLAS M/MAXIMIS 45mm 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
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. S060-045
  • Known Lot No. WNV101015.

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 →

Related recalls

Same manufacturer · Valorem Surgical LLC

See all →

Same hazard · quality system non compliance

See all →

Similar recalls