The Recall Desk
ModerateFDA (Devices)·Z-3003-2017·Announced 2017-08-16

Valorem Surgical Recalls Pallas M Ratchet T Handle for Quality Issues

Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Ratchet T Handles because they do not meet 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, and the source text cites non-compliance with Quality System Requirements without reporting specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Ratchet T Handle, which is part of the MAXIMIS Pedicle Screw Spinal Fixation System. The device is intended for posterior pedicle screw fixation of the non-cervical spine. The product was distributed nationwide, including in California and Virginia, and was labeled as the Pallas M Spinal Fixation System through 2015.

The recall was initiated because the devices are not consistent with Quality System Requirements. The specific catalog number is 0902-1036, and the known lot numbers are WNV111125, WNV111109, WNV120518, and WNV120320.

Healthcare providers and consumers should stop using the affected devices and contact Valorem Surgical LLC for further instructions or a return.

The recalled product

Product
PALLAS M/MAXIMIS Ratchet T Handle. 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
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 (4)

  • Catalog No. 0902-1036. Known Lot No. WNV111125
  • WNV111109
  • WNV120518
  • WNV120320.

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 →