Valorem Surgical Recalls Pallas M Pedicle Screw Extensions for Quality Issues
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Open Extensions 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 explicitly states the devices are not consistent with Quality System Requirements without reporting any specific injuries, illnesses, or deaths, 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 Open Extension (Large), which is part of the MAXIMIS Pedicle Screw Spinal Fixation System. These devices are intended for posterior pedicle screw fixation of the non-cervical spine. The product was distributed nationwide in the United States, including California and Virginia, and 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 specific catalog number is 0902-1010, and the known lot numbers are WNV120820 and WNV101022. The source text does not report any specific injuries, illnesses, or deaths associated with these devices.
Healthcare providers and consumers who have these specific devices should stop using them and contact Valorem Surgical LLC for further instructions on how to return or dispose of the product.
The recalled product
- Product
- PALLAS M/MAXIMIS Open Extension (Large). 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
- 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. 0902-1010
- Known Lot No. WNV120820
- WNV101022.
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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