Valorem Surgical Recalls Pallas M/MAXIMIS Dilator A Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Dilator A due to quality system non-compliance. The devices are used for spinal fixation.
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 injuries, illnesses, or specific physical defects. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm is not yet reported.
Plain-English summary
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Dilator A, a component 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 classified as Class II by the FDA.
The recall was initiated because the devices are not consistent with Quality System Requirements. The affected units were distributed nationwide in the United States, including California and Virginia. Known lot numbers include WNV111108, WNV120802, and WNV111109, with catalog number 0902-1003.
Healthcare providers and patients should stop using the affected devices and contact Valorem Surgical LLC for further instructions. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- PALLAS M/MAXIMIS Dilator A. 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 (4)
- Catalog No. 0902-1003
- Known Lot No. WNV111108
- WNV120802
- WNV111109.
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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