Valorem Surgical Recalls Pallas M Rod Bender for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Benders 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 cites only non-compliance with Quality System Requirements without reporting specific injuries, illnesses, or high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Rod Bender, which is part of the MAXIMIS Pedicle Screw Spinal Fixation System. The product is 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 product is identified by Catalog No. 0703-0015 and Known Lot No. WNV111105. The product was distributed nationwide in the United States, including California and Virginia. The product was labeled as the Pallas M Spinal Fixation System through 2015.
No specific injuries or illnesses have been reported in the source text. Users of the device should contact Valorem Surgical LLC for further instructions regarding the recall.
The recalled product
- Product
- PALLAS M/MAXIMIS Rod Bender. 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. 0703-0015
- Known Lot No. WNV111105.
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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