The Recall Desk
ModerateFDA (Devices)·Z-2963-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Tapper for Quality System Non-Compliance

Valorem Surgical LLC is recalling Pallas M/MAXIMIS Tapper 6.5 devices 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 due to Quality System non-compliance, which typically falls under moderate severity when no specific injuries or illnesses are reported.

Plain-English summary

Valorem Surgical LLC is recalling the Pallas M/MAXIMIS Tapper 6.5, 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 product is identified by Catalog No. 0703-0005 and Known Lot No. WNV111130. The devices were distributed nationwide in the United States, including California and Virginia. The product was labeled as the Pallas M Spinal Fixation System through 2015.

This is a Class II recall. No specific injuries or illnesses have been reported in the source text. Healthcare providers and patients should contact Valorem Surgical LLC for further instructions regarding the return or replacement of these devices.

The recalled product

Product
PALLAS M/MAXIMIS Tapper 6.5. 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 Implant
Hazard

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. 0703-0005
  • Known Lot No. WNV111130.

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 →