Valorem Surgical Recalls Pallas M Pedicle Screw Fixation System
Valorem Surgical is recalling 262 units of the Pallas M/MAXIMIS Reduction B. part of the MAXIMIS Pedicle Screw Spinal Fixation System because the devices 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 explicitly states the issue is non-compliance with Quality System Requirements without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Reduction B. part of the MAXIMIS Pedicle Screw Spinal Fixation System. The product, manufactured in Chicago, IL, is intended for posterior pedicle screw fixation of the non-cervical spine. The recall is being conducted because the devices are not consistent with Quality System Requirements.
The affected products are identified by Catalog No. 0703-0028 and known Lot Nos. WNV110406 and WNV110307. The products were distributed nationwide in the US, including California and Virginia. The product was labeled as the Pallas M Spinal Fixation System through 2015.
This recall is classified as Class II by the FDA. The source text does not report any specific injuries, illnesses, or deaths associated with the use of these devices. Healthcare providers and patients should contact Valorem Surgical for further instructions regarding the return or replacement of these units.
The recalled product
- Product
- PALLAS M/MAXIMIS Reduction B. 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. 0703-0028
- Known Lot No. WNV110406
- WNV110307.
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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