Valorem Surgical Recalls Pallas M Poly Screw Drivers for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Poly Screw Drivers 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 does not report any injuries, illnesses, or deaths, and the hazard is a quality system non-conformance rather than a direct physical defect causing harm.
Plain-English summary
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MISS/MIS Poly Screw Driver. This device is part of the MAXIMIS Pedicle Screw Spinal Fixation System and is intended for posterior pedicle screw fixation of the non-cervical spine. The product was distributed nationwide in the United States, including California and Virginia. The specific catalog number is 0902-1020, and the known lot numbers are WNV111108 and WNV120424.
The recall was initiated because the devices are not consistent with Quality System Requirements. The source text does not report any specific injuries, illnesses, or deaths associated with these units. The FDA has classified this recall as Class II.
Healthcare providers and consumers who have these specific devices should stop using them and contact Valorem Surgical LLC for further instructions on return or replacement.
The recalled product
- Product
- PALLAS M/MAXIMIS MISS/MIS Poly Screw Driver. 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
- Category
- Medical Device — Spinal Fixation
- 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 (2)
- Catalog No. 0902-1020. Known Lot No. WNV111108
- WNV120424.
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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