Valorem Surgical Recalls Pallas M Extension Sleeves for Quality System Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Sleeves 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, 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 262 units of the Pallas M/MAXIMIS Extension Sleeve, 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 products are identified by Catalog No. 0902-1018 and known Lot Nos. WNV120806 and WNV110322. The devices were distributed nationwide in the United States, including California and Virginia. The product was labeled as the Pallas M Spinal Fixation System through 2015.
Healthcare providers and facilities should stop using the affected devices and contact Valorem Surgical LLC for further instructions on the recall.
The recalled product
- Product
- PALLAS M/MAXIMIS Extension Sleeve. 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 (3)
- Catalog No. 0902-1018
- Known Lot No. WNV120806
- WNV110322.
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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