Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 2,225 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 due to non-compliance with Quality System Requirements. Per the rubric, this falls under 'voluntary precautionary recalls' or minor regulatory deviations where no specific injury or illness is reported in the source text.
Plain-English summary
Valorem Surgical LLC is voluntarily recalling 2,225 units of Pallas M/MAXIMIS MIS Pedicle Screws. The affected 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 specific sizes involved are 5.5 x 45mm, 5.5 x 4.0mm, and 7.5 x 45mm.
The recall was initiated because the devices are not consistent with FDA Quality System Requirements. The agency has classified this recall as Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected products were distributed nationwide in the United States, including California and Virginia. The products were labeled as the Pallas M Spinal Fixation System through 2015. Known lot numbers include WNV130510, WNV120275, NHS160219, NHS170323, and NHS150813. The catalog number is PM755-045. Healthcare providers and patients should contact Valorem Surgical LLC for further information regarding the recall and potential replacement or refund.
The recalled product
- Product
- PALLAS M/MAXIMIS MIS Screw 5.5 x 45mm & 5.5 x 4.0mm, and 7.5 x 45mm. 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-c
- 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 (7)
- Catalog No. PM755-045
- Known Lot No. Unknown
- WNV130510
- WNV120275
- NHS160219
- NHS170323
- NHS150813.
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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