Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical is recalling Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with FDA 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 non-compliance with Quality System Requirements without reporting specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Valorem Surgical LLC is recalling 2,225 units of PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm, which are part of the MAXIMIS Pedicle Screw Spinal Fixation System. The devices are intended for posterior pedicle screw fixation of the non-cervical spine. The recall is being conducted because the devices are not consistent with Quality System Requirements.
The affected products were distributed nationwide in the United States, including California and Virginia. The specific catalog number is P765-040, and the known lot numbers are WNV120322, WNV110512, WNV120427, and WNV120413. The product was labeled as the Pallas M Spinal Fixation System through 2015.
Healthcare providers and patients should check their inventory and medical 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 MIS Screw 6.5 x 40mm. 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
- 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 (5)
- Catalog No. P765-040
- Known Lot No. WNV120322
- WNV110512
- WNV120427
- WNV120413.
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.
See all 144 products in this recall →Related recalls
Same manufacturer · Valorem Surgical LLC
See all →- ModerateValorem Surgical Recalls Pallas M/MAXIMIS 40mm Rods for Quality Issues
FDA (Devices) · 2017-08-16
- ModerateValorem Surgical Recalls Pallas M/MAXIMIS MIS Tapper 5.5mm Spinal Fixation Devices
FDA (Devices) · 2017-08-16
- ModerateValorem Surgical Recalls Pallas M/MAXIMIS 60mm Spinal Fixation Rods
FDA (Devices) · 2017-08-16
- ModerateValorem Surgical Recalls Pallas M Tapper Spinal Fixation Devices
FDA (Devices) · 2017-08-16
- ModerateValorem Surgical Recalls Pallas M 50mm Curved Rods for Quality Issues
FDA (Devices) · 2017-08-16
Same hazard · quality system non compliance
See all →- HighDiagnostic test products recalled by Universal Meditech for missing FDA clearance
FDA (Devices) · 2023-11-01
- HighUnauthorized Distribution of Multiple Diagnostic Tests Recalled by Universal Meditech
FDA (Devices) · 2023-11-01
- ModeratePregnancy test strips recalled for lack of FDA authorization and quality documentation
FDA (Devices) · 2023-11-01