Valorem Surgical Recalls Pallas M Pedicle Cut Devices for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS MIS Pedicle Cut 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, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a quality system non-conformance rather than a direct physical defect causing harm.
Plain-English summary
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MIS Pedicle Cut, which is part of the MAXIMIS Pedicle Screw Spinal Fixation System. The devices are intended for posterior pedicle screw fixation of the non-cervical spine. The product 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 affected units are identified by Catalog No. 0902-1005 and known Lot Nos. WNV120320 and WNV110826.
The devices were distributed nationwide in the United States, including California and Virginia. The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with the use of these devices.
The recalled product
- Product
- PALLAS M/MAXIMIS MIS Pedicle Cut. 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
- 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 (3)
- Catalog No. 0902-1005
- Known Lot No. WNV120320
- WNV110826.
Distribution
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.
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