The Recall Desk
HighFDA (Devices)·Z-2897-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Set Screws for Quality System Non-Compliance

Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Set Screws because they are not consistent with FDA Quality System Requirements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which falls under the 'High' severity category in the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Valorem Surgical LLC is recalling 2,225 units of the Pallas M/MAXIMIS Set Screw, 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 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 specific catalog number is N009-000. Known lot numbers include NHS160219, NHS151030, WNV120323, WNV110427, WNV101206, WNV120320, WNV120321, and NHS150813. The product was labeled as the Pallas M Spinal Fixation System through 2015.

This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. No specific injuries or illnesses are reported in the source text.

The recalled product

Product
PALLAS M/MAXIMIS Set 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 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 (9)

  • Catalog No. N009-000
  • Known Lot No. NHS160219
  • NHS151030
  • WNV120323
  • WNV110427
  • WNV101206
  • WNV120320
  • WNV120321
  • NHS150813.

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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