The Recall Desk
ModerateFDA (Devices)·Z-2915-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with 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 due to non-compliance with Quality System Requirements, which typically poses a temporary or medically reversible health risk. No specific injuries or illnesses are reported in the source text.

Plain-English summary

Valorem Surgical LLC is recalling 2,225 units of Pallas M/MAXIMIS MIS Pedicle Screws (6.5 x 45mm and 6.5 x 4.5mm). These devices are part of the MAXIMIS Pedicle Screw Spinal Fixation System and are intended for posterior pedicle screw fixation of the non-cervical spine. The products were distributed nationwide, including in California and Virginia.

The recall was initiated because the devices are not consistent with Quality System Requirements. The FDA has classified this as a Class II recall. Specific lot numbers include WNV120420, WNV120322, NHS150153, WNV120427, and WNV120430, with catalog number P765-045.

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

The recalled product

Product
PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm and 6.5 x 4.5 screw. 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 sp
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 (7)

  • Catalog No. P765-045
  • Known Lot No. Unknown
  • WNV120420
  • WNV120322
  • NHS150153
  • WNV120427
  • WNV120430.

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 →