Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 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 failure to meet Quality System Requirements without reporting specific injuries, illnesses, or deaths, which aligns with the criteria for a moderate severity score.
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 product 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 affected products were distributed nationwide in the United States, including California and Virginia. The catalog number is P765-050, and the known lot numbers are WNV110513, WNV120430, WNV120540, WNV120322, and WNV120372.
Healthcare providers and patients should contact Valorem Surgical LLC for further information regarding the recall and potential replacement or refund options.
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 (7)
- Catalog No. P765-050
- Known Lot No.Unknown
- WNV110513
- WNV120430
- WNV120540
- WNV120322
- WNV120372.
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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