The Recall Desk
ModerateFDA (Devices)·Z-3014-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Set Screw Starter Instruments

Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Set Screw Starters 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 the source text cites a Quality System Requirement inconsistency without reporting specific injuries, illnesses, or structural defects, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Set Screw Starter, 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 and was distributed nationwide in the United States, including California and Virginia.

The recall was initiated because the devices are not consistent with Quality System Requirements. The specific lot number for the recalled instruments is NHS170405. The product was labeled as the Pallas M Spinal Fixation System through 2015.

No specific instructions for consumers are provided in the source text, as this is a medical device recall typically managed through healthcare facilities and distributors.

The recalled product

Product
PALLAS M/MAXIMIS Set Screw Starter. 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 — Surgical Instruments
Hazard
Affected units
262

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)

  • Instrument
  • Known Lot No. NHS170405.

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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