The Recall Desk
ModerateFDA (Devices)·Z-2873-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M/MAXIMIS Instrument Taps for Quality Issues

Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 5.5 mm Instrument Taps 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 does not report any illnesses or injuries, indicating a theoretical risk or minor labeling/quality issue rather than a direct health hazard.

Plain-English summary

Valorem Surgical LLC is recalling 2,225 units of the Pallas M/MAXIMIS 5.5 mm Instrument Tap. This product is part of the MAXIMIS Pedicle Screw Spinal Fixation System and is intended for posterior pedicle screw fixation of the non-cervical spine. The devices were 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 catalog number is 0902-1007, and the lot number is unknown. The product was labeled as the Pallas M Spinal Fixation System through 2015.

Healthcare providers and patients who have used these devices should contact Valorem Surgical for further information. No specific illnesses or injuries are reported in the source text.

The recalled product

Product
PALLAS M/MAXIMIS 5.5 mm Instrument Tap. 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 — 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 (1)

  • Catalog No. 0902-1007. Unknown Lot No.

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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