Valorem Surgical Recalls Pallas M Pedicle Screws for Quality 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 due to non-compliance with Quality System Requirements, which typically indicates a moderate risk of temporary or medically reversible health consequences.
Plain-English summary
Valorem Surgical LLC is recalling 2,225 units of Pallas M/MAXIMIS 7.5 x 45mm and 7.5 x 4.5 mm screws. These devices are part of the MAXIMIS Pedicle Screw Spinal Fixation System and are intended for posterior pedicle screw fixation of the non-cervical spine. The products were distributed nationwide, including in California and Virginia.
The recall was initiated because the devices are not consistent with Quality System Requirements. The agency classification for this recall is Class II. Known lot numbers include WNV120328, WNV120430, and WNV110513, with one lot number listed as unknown. The catalog number is P775-045.
Healthcare providers and patients should contact Valorem Surgical LLC for further information regarding the recall and potential replacement or refund options.
The recalled product
- Product
- PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5 mm screw. 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 spi
- 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 (5)
- Catalog No. P775-045
- Known Lot No. Unknown
- WNV120328
- WNV120430
- WNV110513.
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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