Valorem Surgical Recalls Pallas M Nut Inserters for Quality System Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Nut Inserters 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 due to non-compliance with Quality System Requirements, which typically corresponds to a moderate severity where the risk of harm is theoretical or low without reported injuries.
Plain-English summary
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Nut Inserter B, 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 units are identified by lot numbers WNV110318 and WNV120809. The products were distributed nationwide in the United States, including California and Virginia. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare providers and consumers should stop using the affected devices and contact Valorem Surgical LLC for further instructions or a return. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PALLAS M/MAXIMIS Nut Inserter 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
- 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)
- Instrument
- Known Lot No. WNV110318
- WNV120809.
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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