Valorem Surgical Recalls Pallas M Extension Drivers for Quality System Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Drivers 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 cites non-compliance with Quality System Requirements without reporting specific injuries, illnesses, or structural defects, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Extension Driver, 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 is being conducted because the devices are not consistent with Quality System Requirements.
The affected products were distributed nationwide in the United States, including California and Virginia. The specific catalog number is 0902-1016, and the known lot numbers are WNV120814 and WNV110322. The product was labeled as the Pallas M Spinal Fixation System through 2015.
Healthcare providers and facilities should check their inventory for these specific catalog and lot numbers. If the product is found, it should be removed from use and returned to Valorem Surgical LLC in accordance with the recall instructions.
The recalled product
- Product
- PALLAS M/MAXIMIS Extension Driver. 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
- 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. 0902-1016
- Known Lot No. WNV120814
- WNV110322.
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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