Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Defects
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws 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, and the source text cites a general Quality System Requirement non-conformity without reporting specific injuries, illnesses, or high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Valorem Surgical LLC is recalling 2,225 units of the Pallas M/MAXIMIS MIS Screw, specifically the 6.5 x 40mm and 6.5 x 4.0 mm sizes. These screws 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 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 PM765-040, and the known lot numbers are NHS150813 and WNV120322. The source text does not specify the exact nature of the quality system non-conformity or report any specific injuries or illnesses associated with the use of these devices.
Healthcare providers and patients who have received these specific pedicle screws should contact Valorem Surgical LLC for further instructions on how to proceed with the recall. The source text does not provide specific contact details or a timeline for the resolution of this quality system issue.
The recalled product
- Product
- PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. 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
- Manufacturer
- Valorem Surgical LLC
- Hazard
- Affected units
- 2,225
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. PM765-040
- Known Lot No. Unknown
- NHS150813
- WNV120322.
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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