Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling Pallas M/MAXIMIS MIS Pedicle Screws 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 only non-compliance with Quality System Requirements without reporting specific injuries, illnesses, or structural failures, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Valorem Surgical LLC is recalling 2,225 units of Pallas M/MAXIMIS MIS Screws, specifically the 6.5 x 50mm and 6.5 x 5.0 mm sizes. 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 products were distributed nationwide in the United States, including California and Virginia.
The recall was initiated because the devices are not consistent with Quality System Requirements. The specific catalog number is PM765-050. Known lot numbers include NHS160219 and WNV120322, though some lot numbers are unknown. The product was labeled as the Pallas M Spinal Fixation System through 2015.
Healthcare providers and patients should check their inventory and records for these specific screw sizes and lot numbers. If you have used or possess these devices, contact Valorem Surgical LLC for further instructions on how to proceed.
The recalled product
- Product
- PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 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
- 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. PM765-050
- Known Lot No. Unknown
- NHS160219
- 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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