Valorem Surgical Recalls Pallas M/MAXIMIS Dilator Handles for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Dilator Handles because they are not consistent with Quality System Requirements. The devices are part of a spinal fixation system.
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 hospitalizations, injuries, or deaths, and the defect is a quality system inconsistency rather than a direct physical hazard like a structural failure or contamination.
Plain-English summary
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Dilator Handle, which is 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 specific catalog number is 0902-1002, and the known lot number is WNV120802.
The recall was initiated because the devices are not consistent with Quality System Requirements. The agency has classified this as a Class II recall. The products were distributed nationwide in the US, including California and Virginia.
No specific illnesses or injuries are reported in the source text. Consumers and healthcare providers should stop using the affected devices and contact Valorem Surgical LLC for further instructions.
The recalled product
- Product
- PALLAS M/MAXIMIS Dilator 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
- 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 (2)
- Catalog No. 0902-1002
- Known Lot No. WNV120802.
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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