Valorem Surgical Recalls Pallas M/MAXIMIS 60mm MIS Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 60mm MIS Rods 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 illnesses, injuries, or hospitalizations. The hazard is a quality system non-conformance without reported harm, fitting the Moderate criteria for low-risk or theoretical hazards.
Plain-English summary
Valorem Surgical LLC is recalling 2,225 units of the Pallas M/MAXIMIS 60mm MIS Rod, 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 due to the devices not being consistent with Quality System Requirements.
The affected products were distributed nationwide in the United States, including California and Virginia. The specific catalog number is M058-060. Known lot numbers include WNV120322, and there are also units with unknown lot numbers. The product was labeled as the Pallas M Spinal Fixation System through 2015.
Healthcare providers and facilities should check their inventory for these specific rods and stop using them if they match the description. Consumers are not directly affected as this is a medical device used in surgical procedures.
The recalled product
- Product
- PALLAS M/MAXIMIS 60mm MIS Rod. 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 (2)
- Catalog No. M058-060
- Known Lot No. WNV120322 & Unknown.
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.
See all 144 products in this recall →Related recalls
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