Valorem Surgical Recalls Pallas M/MAXIMIS Closed Extension Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Closed Extension devices 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, but the source text cites non-compliance with Quality System Requirements without reporting specific injuries, illnesses, or structural defects, aligning with the criteria for moderate severity.
Plain-English summary
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Closed Extension devices. These devices are part of the MAXIMIS Pedicle Screw Spinal Fixation System and are intended for posterior pedicle screw fixation of the non-cervical spine. The product was labeled as the Pallas M Spinal Fixation System through 2015.
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. The specific catalog number is 0902-1012, and the known lot numbers are WNV120820, WNV110821, WNV110311, and WNV120914.
Healthcare providers and patients should check their inventory and patient records for these specific lot numbers. If the devices are found, they should be removed from use and returned to Valorem Surgical LLC according to the company's instructions.
The recalled product
- Product
- PALLAS M/MAXIMIS Closed Extension. 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 (5)
- Catalog No. 0902-1012
- Known Lot No. WNV120820
- WNV110821
- WNV110311
- WNV120914.
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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