Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 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. The source text cites non-compliance with Quality System Requirements without reporting specific injuries, illnesses, or structural defects, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Valorem Surgical LLC is recalling 2,225 units of the Pallas M/MAXIMIS Polyaxial and MIS Screw, 5.5 x 45mm. This product 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 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 are identified by Catalog No. P755-045 and known Lot Nos. WNV110511, WNV120413, WNV120322, WNV120427, and WNV130510.
The products were distributed nationwide in the US, including California and Virginia. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- PALLAS M/MAXIMIS Polyaxial and MIS Screw, 5.5 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-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 (6)
- Catalog No. P755-045
- Known Lot No. WNV110511
- WNV120413
- WNV120322
- WNV120427
- WNV130510.
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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