Valorem Surgical Recalls Pallas M/MAXIMIS C. Spinal Fixation Probes
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS C. probes used in spinal fixation systems 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, but the source text explicitly states the issue is non-compliance with Quality System Requirements without reporting any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS C. Probe, which is part of the MAXIMIS Pedicle Screw Spinal Fixation System. These instruments are 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 lot number for the recalled instruments is WNV111118.
The recall was initiated because the devices are not consistent with Quality System Requirements. The source text does not specify the exact nature of the quality system deviation or report any illnesses, injuries, or deaths associated with the use of these probes.
Healthcare providers and facilities that have received these instruments should stop using them and contact Valorem Surgical LLC for further instructions. Consumers are not typically the end-users of these professional medical instruments, but patients who have had these devices used during surgery should consult their healthcare provider if they have concerns.
The recalled product
- Product
- PALLAS M/MAXIMIS C. Probe. 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
- 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)
- Instrument
- Known Lot No. WNV111118.
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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